Job Opportunities at Parexel

About This Role

• As an experienced Biostatistician, you will lead research design and analytical strategies, provide input into protocols, develop and review statistical analysis plans and author/co-author reports, abstracts and manuscripts. You will use your knowledge to advise, provide guidance and to oversee the quality control of statistical deliverables. As the functional lead within a study team, you will direct the Biostatistical activities on a study and be accountable for the deliverables. Senior and Principal level Biostatisticians at Parexel are client-facing and play an integral part in the study team.
• Our Biostatistics teams are not only focused on delivering quality results for our client’s needs, but also value working with one another in a flexible environment. Although some team members are home-based and others are office-based, our virtual resources support our teams to work collaboratively and effectively across the globe. The overall long tenure of our team integrates a depth of knowledge and experience. Working together, you will create paths to answers and contribute to new therapies which ultimately will impact the patient. 

What you’ll do...

Supervise, advise and review:

• Leverage your expertise. Develop complex analysis strategies and execute them using efficient programming techniques (software: SAS, R).
• Foster teamwork. Perform intricate statistical analyses and provide input to statistical reports. 
• Share knowledge. Provide input to analysis plans, statistical reports, statistical sections of integrated clinical reports.
• Impact the process. Be a proactive advisor for all types of analysis from the proposal process through the project life cycle.
• Take quality seriously. Review analysis data sets and quality control all types of statistical analysis deliverables.
• Coach and mentor. Train and uplift junior members of the department.

Cooperate and network:

• Build relationships. Liaise with other biostatistical and company departments to optimize global efficiency.
• Work collaboratively. Coordinate Biostatistics related project activities for successful completion within given timelines and budget.
• Interact with heart. Coordinate with clients with regard to data analysis, scope of work, and budget.
• Demonstrate our expertise. Represent Parexel at client meetings.

More about you...

On your first day we’ll expect you to have:

Experience:

• A minimum of 5 years industry (or directly relevant) experience 
• A thorough understanding of the statistical aspects of either clinical trials and/or observational studies
• Experience in statistical analysis in a clinically related subject, either within clinical trials or in Epidemiology
• SAS programming or R programming skills (desired)

Education:

• A Masters or Ph.D. level education in biostatistics, statistics, mathematics, or another relevant discipline 

Skills:

• Confidence, be self-reliant and a quick learner who enjoys working in a matrixed team
• Good leadership skills
• Strong oral and written English communication skills
• The ability to travel as required, although this is not frequent
• A strong work ethic to promote the development of life changing treatments for patients

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About This Role

• The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, acts as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programing activities related to the analysis and reporting of clinical study data. In addition, the Senior Statistical Programmer can fill the Statistical Programming Lead role on projects, and liaise with sponsors, Biostatistics Leads, Data Management Leads, and other functional areas as required. Further, the Senior Statistical Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets.

Essential Skills Required for this Senior Statistical Programmer role:

Excellent analytical skills.

• Proficiency in: SAS, SDTM, CDISC, ADaM
• Extensive knowledge and understanding of the programming and reporting process with sound Statistical Programming (Clinical) experience within related industry (minimum 3.5+ years)
• Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.
• Ability to learn new systems and function in an evolving technical environment.
• Strong project management skills.
• Strong organizational skills, ability to manage competing priorities, and flexibility to change.
• Attention to detail.
• Ability to successfully lead a global team.
• Work effectively in a quality-focused environment.
• Effective time management in order to meet daily metrics or team objectives.
• Show commitment to and perform consistently high quality work.
• Business/operational skills that include customer focus, commitment to quality management, and problem solving.
• Demonstrate commitment to refine quality processes.
• Good presentation skills.
• Good business awareness/business development skills (including financial awareness).
• Senior Statistical Programmer Knowledge and Experience Required:
• Competent in written and oral English.
• Excellent communication skills.

Education:

• Educated to degree level in a relevant discipline and/or equivalent work experience.
• Key Accountabilities / Responsibilities of this Role:

Project Management:

• Ability to fill Statistical Programming Lead role on projects
• Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to.
• Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget.
• Monitor project resourcing, project budgets, and identify changes in scope.
• Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.
• Review statistical analysis plans and mock-shells.
• Review database set-up specifications.
• Interact with sponsors and internal stakeholders with regard to statistical programming issues.
• Assist project teams in the resolution of problems encountered in the conduct of their daily work.

Statistical Programming for Assigned Projects:

• Deliver best value and high quality service.
• Check own work in an ongoing way to ensure first-time quality.
• Use efficient programming techniques to produce/QC derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings.
• Produce/QC dataset specifications and other process supporting documents and submission documentation.
• Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and/or other international regulatory requirements.

Training:

• Maintain and expand local and international regulatory knowledge within the clinical industry.
• Develop knowledge of SAS and processes/procedures within other Parexel functional areas.
• Provide relevant training and mentorship to staff and project teams.

General:

• Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.
• Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required.
• Proactively participate in and/or lead process/quality improvement initiatives.
• Provide consultancy to internal and external sponsors with regard to statistical programming tasks.
• Represent Parexel at sponsor marketing and technical meetings.
• Understand regulatory requirements concerning industry technical standards(e.g. CDISC, 21 CFR Part 11, and electronic submissions).

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About This Role

• We are looking for a Senior Regulatory Affairs Associate with working knowledge of Clinical Trial Applications (CTA) to join our team in South Africa! This role can be office based (Bloemfontein) or home based anywhere in South Africa.
• As a Senior Regulatory Affairs Associate, you will ensure the timely performance of work within a project scope to the quality expectations of internal stakeholders and clients. You will bring your specialist knowledge of clinical trial submissions in Sub-Saharan countries. Aa s Senior Associate, under the general direction of a Project Lead and/or Technical SME, you will take responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of Parexel and our clients. You may take up a client facing role with support from line management.

Key Deliverables in the role:

• Manage the local submissions (as Local Regulatory Contact - LRC)
• Coordinate the regulatory submissions in all participating countries as Regulatory Lead.
• Regulatory submission of Clinical Trial in the region
• ​​​Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary.
• You may lead or be involved in local, regional, and/or global projects
• Guide and mentor junior team members

Skills and Experience required for the role:

• University degree in a science discipline
• Background in clinical trial management
• 3-5 years of Regulatory Affairs experience working with Clinical Trail Applications in South Africa
• Experience with clinical trial submissions in other Southern African Countries
• IT knowledge (Veeva Regulatory and Clinical Vaults - excel – VBA – powerBI)
• Customer-oriented and autonomous
• Fluency in English is a must along with the local language.

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About This Role
Role is remote - it can be based in select EMEA locations.

Picture Yourself At Parexel:

• The Biometrics Delivery Lead (DL), reporting into the Global Biometrics Account Lead (AL) has overall accountability for the execution of the Data Operations strategy and the Data Operations technology set up for the EMEA project.The DL provides overall leadership/management for database programming, data integration, data management, statistical services and medical writing on a project/program.General areas of responsibility include oversight of the Global Data Operations team members and their activities across all geographies, liaising with the AL, other functional leaders (both in GDO and across Parexel), and the client as a single point of contact to ensure that the Data Operations deliverables regarding timelines, resourcing, quality, and productivity are being met. The DL will be responsible for managing budgets and resourcing for assigned studies.The DL may take on some AL responsibilities for projects involving a small number of services, where no account lead is assigned.

What You'll Do At Parexel:

Global Data Organization (GDO) Strategic Support

• Provide an extensive range of leadership and influencing capabilities to achieve the business objectives and goals for both Parexel and clients
• Effectively communicate with internal and external customers as well as third party vendors
• Participate in cross functional meetings and support initiatives to ensure the delivery of milestones and timelines for clinical trials
• Ensure all systems both technical/non-technical are set up for complex projects/programs
• Responsible for the creation and execution of a project timelines plan covering all GDO deliverables; this includes the coordination of dependencies between Data Operation stakeholders (Data Management, Programming, Biostatistics) either within Parexel or at a client
• Work with study teams and Data Standards Associates to ensure enforce the use of data standards as applicable
• Provide technical knowledge and oversight and serve as an escalation point where appropriate
• Remain informed about developments in relevant regulations and guidelines

Team Management

• Provide an extensive range of leadership and influencing capabilities to achieve the business objectives and goals for both Parexel and clients
• Effectively communicate with internal and external customers as well as third party vendors
• Participate in cross functional meetings and support initiatives to ensure the delivery of milestones and timelines for clinical trials
• Ensure all systems both technical/non-technical are set up for complex projects/programs
• Responsible for the creation and execution of a project timelines plan covering all GDO deliverables; this includes the coordination of dependencies between Data Operation stakeholders (Data Management, Programming, Biostatistics) either within Parexel or at a client
• Work with study teams and Data Standards Associates to ensure enforce the use of data standards as applicable
• With assistance provide input to proposals and attend Bid Defense meetings as required
• As needed and with guidance, participate in a meeting with Business Development/CDD/PL/PM to understand the scope of the contract and any Master Service Agreement in place for the client
• Ensure the operational team reviews the draft protocol from a Data Operations perspective
• Attend project kick off meetings and other project related meetings
• Review and collate information required for the project tools, project plan, TMF, resourcing, etc. in collaboration with the PL/PM.
• In cooperation with the PL/PM accountable for the deliveries from the technology/data integration team (if applicable)
• Accountable for ensuring all team members access to tools and documents as required
• Establish efficient/effective working relationships with other functional leaders and experts
• With assistance provide leadership and direction to the project team members
• Communicate project metric targets to the project team members and guide team towards achieving them

Ideal candidate will possess:

• Several years’ experience within CRO/Pharma/Biotech
• Demonstrated application of project management concepts
• Proven record of leading a project team in a technical/programming, data management or statistical environment with minimal supervision
• Proficient understanding of cross-functional activities
• Bachelor’s degree in a science or industry related discipline
• Fluent English
• Ability to successfully manage a full workload across multiple and varied studies with enthusiasm and prioritize workload with attention to detail
• Knowledge of SOPs/guidelines, ICH-GCP and other applicable local and international regulations
• Understanding of the needs and use of data standards in the clinical trial environment
• Project management skills such as improving presentation skills, public speaking foundations, speaking confidently and effectively, boosting your confidence, public speaking and performance, delivery tips for speaking in public, Centered communication: get better results from your conversations, critical thinking and building trust
• Ability to work effectively with and motivate virtual teams within different cultural environments
• Proficient negotiation and diplomacy skills

Why join us:

• Opportunity to work on innovative projects at the forefront of the industry.
• Collaborative and inclusive work environment that values your expertise.
• Professional advancement and development opportunities.
• Work life balance and flexible working hours.

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About this Role

• Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.
• The main responsibility of the Site Contract Lead is the negotiation of study specific generic and country Clinical Site Agreement (CSA) templates with the Sponsor and support the PL in the negotiation of country budgets with the Sponsor as well as providing the local CTS/CRA with required CSA country templates.
• Further, the responsibilities include managing CSA activities and liaising with PL, GRO Lead and the Sponsor to ensure that the CSA start-up deliverables are met. The Site Contract Associate is responsible for the coordination of the local CTS /CRA working on CSAs on a project level.

Key Accountabilities:

• Act as functional Specialist on projects and develop study specific CSA strategy
• Agree and negotiate study specific generic and country CSA templates with the Sponsor and
• support the PL in the negotiation of country budgets with the Sponsor
• Gather relevant study information from PL
• Discuss and finalize specific country CSA templates with input from Sponsor, PL and GRO Lead if appropriate
• Upon sponsor approval of the country specific template, store the final approved and complete country template and country budget PMED
• Communicate CSA strategy, CSA turnaround timelines, CTMS tracking requirements and budget information/updates with the assigned CTS/CRAs
• Provide agreed study and country CSA templates to local CTS/CRA for country specific adaptation
• Coordinate interaction between GRO Lead, PL and Sponsor including overall timeline management for CSAs
• Coordinate overall CSA process with assigned CTS/CRA and status reporting to GRO-Lead/PL
• Provide updates about template amendments, process changes, investigator fees, local requirements etc. to ensure that relevant CSA database is up-to-date
• Maintain comprehensive language tracker
• Early recognition of areas of potential problems and formulate contingency plans
• Define solutions strategy of significant CSA changes requested by the site whereas minor
• administrative changes to be done by local CTS/CRA
• Evaluate and identify resourcing needs of SSU staff to be assigned on the project and provide
• performance feedback as appropriate
• Participate in client, investigator and team meetings
• Identify and facilitate CSA training needs of local CTS/ CRA
• Maintain and assure quality of work generated
• Compile CSA status within a project as agreed with PL and GRO Lead
• Prioritize effectively and respond to urgent requests within team or sponsor lead
• Provide mentoring and coaching to CTS staff
• Resolve negotiation issues that have arisen at the clinical site and escalated from the CTS that
• cannot be resolved by the CTS after several attempts.
• Escalate changes that fall outside the documented “fall-back” parameters, if available to the Sponsor or to Clinical Site Agreement Manager as appropriate.
• Provide internal and Sponsor approval to CTS for signature of the fully agreed CSA according
• to applicable PAREXEL or Client instructions
• Maintain a working knowledge of, and ensure compliance with applicable ICH-GCP
• Guidelines, local regulatory requirements, and PAREXEL WSOPs and study specific procedures
• Complete routine administrative tasks in a timely manner (e.g. Timesheets, metrics, travel expense claims).

Requirements;

• Experienced CRA, CTS or a senior person with a legal or business degree or other relevant experience, preferably in one of the following environments: Contracting, Clinical Operations, Legal (Paralegal) or in a comparable function in another CRO or pharmaceutical company.
• Global Site Contract Lead experience.
• Excellent computer and internet skills including excellent knowledge of MS- Office products such as Excel, Word
• Possess strong negotiation, diplomacy, team leadership skills and excellent organizational ability
• Excellent interpersonal, verbal and written communication skills
• Ability to motivate both individuals and a team.
• Ability to successfully work in a “virtual” team environment
• Ability to complete tasks in an accurate, timely manner and effectively manage multiple tasks
• Shows commitment to and performs consistently high quality work
• Ability to identify and address issues proactively in a timely manner
• Ability to take initiative, work independently and delegate

Education

• Degree in business, legal or life science or other relevant work experience in Contracting, Clinical Operations or in Legal (Paralegal)

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Job Purpose

• The Senior Medical Director is responsible for providing leadership and directions to the Safety Medical Sciences business functions and other assigned business functions, as well as provide strategic inputs to Safety Services Leadership.
• The Senior Medical Director is also responsible for implementation of suitable technology and innovations for the function and acts as Business Owner of related systems and Process Owner for applicable SOPs.

You will also:

• Represent function/department at various internal and external forums.
• Contribute significantly to thought leadership activities.
• Responsible for resource management, overall quality, business continuity, utilization and profitability.

Key Accountabilities

• Maintaining an excellent knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
• Maintaining an excellent awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
• Attending, proving consultations and/or presenting at client/cross functional meetings along with other stakeholders. Working as Subject Matter Experts (SMEs)
• Overall responsible for quality of the function and function’s Key Performance Indicators (KPIs) targets
• Works in collaboration with Safety Services Leadership Team and provide strategic and competitive inputs to the department and organization
• Performing medical review of cases not limited to (including non-serious and serious spontaneous (including legal cases), clinical trial, and literature cases including combination products {drug-device}) according to client/Parexel Standard Operating Procedures (SOPs; as applicable) and liaising with the client, as required
• Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality
• Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative
• Reviewing and/or authoring of aggregate reports for medical content and consistency in accordance with client requirements and SOPs
• Review and sign off adverse events report for accuracy and clinical importance, relationship to the study drug as well as for severity and seriousness
• Review and sign off Data Management line listings
• Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs).
• Perform signal detection activities in accordance with client conventions/SOPs and within pre-decided timeframes. Perform medical assessment of safety alerts obtained from data mining activities.
• Author/review SERs. Perform case analysis, review literature summaries, check draft for medical and scientific accuracy and cohesiveness
• Author/review responses to HA requests and other safety documents
• Medical Writers (MWs) authoring SERs, Signal validations etc.
• Managing safety signals on project specific tools (e.g., Signal Tracking System, Signal management tools, etc.)
• Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy, and highlighting and tracking potential issues
• Prepare and review periodic safety reports (PBRER/PSUR, DSUR, European union renewal, HHE and other Annual Safety/addendum reports) in accordance with regulatory requirements and SOPs
• Support the preparation and maintenance of safety sections of the Company Core Data Sheet, local labels and Development Core Safety Information (DSCI)
• Provide safety content review of clinical protocols, study reports, Investigators Brochures, and other related documents 
• Contribute to regulatory agency submissions (Investigational new drug applications, New drug applications, Marketing authorization applications, Variations and Renewals) by reviewing safety data and preparing relevant sections of the filing documents and submission packages
• Participate in or provide input for Drug Safety Monitoring Boards or independent monitoring committee meetings, as applicable
• Therapeutic Area Head (TAH) provides PV expertise, leadership, mentorship, and supervision of involved Therapeutic Area members and personnel assigned to the respective organization to ensure appropriate assessment of Safety information related to assigned products/portfolio
• TAH oversees compliance, quality, procedures, regulations, timeliness, and consistency of all deliverables which include Scheduled Reports, Ad Hoc Reports and Signal Management. Scheduled reports include PBRERs/PSURs, PADERs, Addendums to Clinical Overview, and PBRER/PSUR Addendum Reports. Non-scheduled reports include Ad hoc reports in response to health authority queries or internal requests, health hazard evaluations, and labelling support documents
• Management of Safety Officers, Signal Management Expert(s), Risk Management Expert(s), PV Scientist(s) and administrative assistants
• Ensure alignment of Therapeutic Area objectives, safety strategies and issue escalation with PV
• Oversee continuous evaluation of safety and benefit risk assessment activities and strategies for the Therapeutic Area
• Support for other therapeutic area teams and deputize for the PV Head if required

Knowledge and Experience:

• Extensive drug safety and clinical trial knowledge and experience
• Clinical practice experience
• Managerial and Leadership experience a must
• Very strong knowledge/understanding of medical terminology

Education:

• Doctor of Medicine (MD)/ Medically qualified from an acknowledged Medical School
• Completion of at least a basic training in clinical medicine (residency, internship etc.)

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About this Role

• Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.
• Parexel is looking for a Medical Director with a very strong background in Infectious Disease.
• The role can be based remotely in select EMEA locations.
• The Medical Director is a medical expert with specialized therapeutic expertise and some experience across indications, clients and drug development. They initiate and maintain medical and consultative relationships with clients, consult on early engagement and pre-award efforts and serve as a medical monitor for contracted projects. The Medical Director may take on leadership roles by participating in initiatives, mentoring junior MDs and/or, where appropriate, managing a team of physicians.
• Primary activities will focus on Medical Monitoring Delivery & PV Support. The medical monitor will independently deliver all medical support required for successful delivery of the projects according to contracted agreement with the sponsor (i.e., tasks and time per task contracted) and according to the assigned role (Global Lead Physician or Regional Lead Physician).
• Medical Expertise and experience in Infectious Diseases is essential to the medical monitor role and will be manifested in high quality consultation on protocol development or drug development programs, medical review of various documents, collaboration on internal therapeutic area meetings, training module development, white papers, slide sets, publications etc.
• Client Relationship Building & Engagement, including soliciting and addressing client feedback and suggestions regarding medical study-related activities, are core skills required of the medical monitor.
• Business Development: the medical monitor will provide medical expertise / leadership in Proposal Development Teams (PDTs) for client bid pursuit meetings

Skills:

• Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts
• Client-focused approach to work
• Excellent time management skills
• Excellent verbal and written medical communication skills
• Excellent standard of written and spoken English
• A flexible attitude with respect to work assignments and new learning
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• Willingness to work in a matrix environment and to value the importance of teamwork.

Knowledge and Experience:

• Experience in clinical medicine (general or specialist qualifications) with a specialty in Infectious Diseases, which is expected to be kept up to date
• A background in clinical aspects of drug development, including all aspects of Medical Monitoring and study design/execution
• Clinical practice experience
• Good knowledge of the drug development process including drug safety, preferred
• Experience in Pharmaceutical Medicine, preferred
• Experience leading, mentoring and managing individuals/ a team, preferred

Education:

• Medically qualified in an acknowledged medical school with completion of at least a basic training in clinical medicine (residency, internship)

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About this Role
External Job Description

• We are now looking for a Contracts Specialist. In this role, you will amend, negotiate and finalise project budgets together with creating draft contractual documents.  You will have the opportunity to work closely with colleagues across various departments such as Finance, Legal, Project Management, Business Development and Operational Groups as well as build relationships with Clients and external vendors.

Key Accountabilities

• Prepare draft contract documents, including Start-up Agreements, Work Orders and Change Orders, from Parexel templates per guidance provided by the assigned Contract Manager or Line Manager, and in conjunction with relevant departments
• Amend project budgets as required
• Direct client interaction with established contacts per guidance provided by the assigned Contract Manager or Line Manager
• Provide quality client deliverables to strict deadlines
• Facilitate review and approval in accordance with relevant policies and procedures
• Cooperation with Finance on ongoing budget changes and provide finance system load ready budget tools in accordance with relevant policies and procedures
• Participate in contract review meetings with clients and internal customers
• Review client contractual templates with support from Line Manager/ Contracts Director / LRM and edit as appropriate to ensure Parexel's positions are covered and to highlight areas of potential concern
• Ensure contracts with client edits received back from the client show all the appropriate changes
• Ensure contractual documents are processed into and maintained in relevant databases

Skills and Experience required for the role:

• University Degree (Preferably in Finance or Business) or equivalent
• Knowledge of contract management principles
• Experienced Excel user (experience working with formulas)
• CRO experience and Early Phase experience - nice to have
• Highly organized with excellent oral and written communication skills
• Excellent analytical, problem-solving skills and attention to detail
• Experience dealing with senior stakeholders
• Negotiation skills
• Fluent in English, oral and written