Job Opportunities at parexel

We have an exciting opportunity to join the Parexel team as a Director of Risk Management! In this role, you would be charged with developing and continuously improving the corporate Risk Management and Management Review framework, and related standards. You would work with the Head of QSPM to execute Corporate Quality's strategy and Parexel's QMS. In this position, you would engage with stakeholders across the organisation, right through to Executive Leadership level and sit on key decision making committees.

Key Accountabilities;

• Work with Parexel's leadership to continuously improve the QMS.
• Manage projects and initiatives as assigned, including participants, reporting and escalations as needed.
• Support management of the QSPM budget.
• Maintain a positive, results oriented work environment, building partnerships within the group and across the organization at large, modeling teamwork.
• Maintain a familiarity with Parexel QMS-related applications and related processes.
• Recruit qualified staff and ensure that they are appropriately trained.
• Provide staff with opportunities for continuous learning and development.
• Ensure that performance objectives and a development plan are documented for each direct report and that these are reviewed at least annually.
• Provide coaching, mentoring and constructive feedback to direct reports, and where appropriate, to indirect reports.
• Ensure that resources are adequate. If they are not, either obtain the necessary resources or reprioritize work according to available resources.
• Communicate to employees in an open, balanced and objective manner.
• Empower employees to be the best that they can be.
• Provide technical knowledge and oversight and serve as an escalation point where appropriate.
• Remain informed about developments in relevant regulations and guidelines.
• Maintain a framework for Regulatory Intelligence knowledge sharing throughout the organization.
• Support Corporate Quality in the preparation for and follow up of internal/external audits and inspections as required.

Qualifications

• Knowledge and understanding of international and industry-level Risk Management regulations and guidelines
• Experience in clinical trials and GxP
• Experience in Risk management methodology, tools and techniques
• Leadership experience required
• Excellent interpersonal, verbal and written communication skills
• Client focused approach to work
• Have a flexible approach with respect to work assignments and new learning
• Ability to manage multiple and varied tasks with enthusiasm, work independently, be comfortable with ambiguity, take initiative, prioritize workload with attention to detail and strong organizational skills
• Ability to successfully manage staff and/or assigned teams
• Willingness to work in a matrix environment and to value the importance of teamwork in the group as well as across the organization.
• Strong ability to analyze and interpret data
• Understanding of audit/inspection process
• Strong analytical skills
• Culturally aware and ability to think and work globally
• Ability to travel internationally as needed for the position
• English proficiency (written and oral English)
• Educated to degree level (biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
• Master’s degree in a science, technology or industry related discipline, preferred
• Risk Management certification desirable

go to method of application »

The Functional Service Provider (FSP) division of Parexel is seeking a candidate for a Senior, hands-on Data Manager role. This individual will work with the Clinical Trial Team at a Top 5 Pharma company, behaving as if they are employed directly at this Pharma. The Senior Data Manager will interact directly with the Data Management Team Lead and occasionally with Clinical Project Leaders, Medical Directors, Biostatisticians, Statistical Programmers and Medical Writers. Individuals selected for this role will receive mentoring and oversight support as they transition in experience where they can offer the same to their peers. This opportunity includes oversight for Phase Ib and II Global Oncology studies lasting 2-4 years, allowing full experience from Protocol Review & Database Development through Database Lock. Individuals in this role will gain experience with data deliveries through the life of the trial, including working on submissions to regulatory authorities.

Main Activities Will Include

• Provide data management input on Clinical Trial teams.
• Performs DM activities for startup of a study including preparing the eCRF, CCGs where needed, Data Handling plan (DHP) Data Review Plan (DRP) and performing user acceptance testing (UAT) as applicable
• Manage local lab set up for the Clinical Database as applicable
• Under supervision ensures consistency of assigned trials with program level standards
• Understands third party data requirements and begins to gather an understanding of new technologies that may be used in the course of clinical trials
• Performs ongoing review of all data generated from the clinical study including Third party and local lab data as well as SAE reconciliation where applicable
• Ensures activities that are performed are done with quality and understanding of the process
• Verifies and tracks eCRF completion including Query resolution and provides data status updates as needed
• With support from the Trial Data Manager develops proposals to resolve issues that may occur during the running of assigned trials.
• With support from the Trial Data Manager gives input into Study Specification worksheets should assigned trials need to be outsourced.
• Has a working knowledge of FDA and ICH guidelines.

Ideal Candidate Will Possess

• Experience in clinical research (Pharma/CRO).
• Bachelor’s degree as a minimum.
• Proven ability to lead and collaborate with global and cross-functional teams - ability to coordinate & prioritize tasks for the DM operational and programming teams (when) in the Senior CDA role.
• Ability to independently interact with Sponsor liaison to discuss data issues/project data validation requirements, as needed.
• Experience and understanding of Global Data Operations tasks, specifically within Data Management and Database Programming and relevant data standards.
• Excellent interpersonal, verbal and written communication skills.
• Knowledge of medical terminology and awareness of coding dictionaries (e.g. MedDRA & WHODRUG).
• Robust knowledge of ICH-GCP Guidelines.
• Good knowledge of EDC systems (e.g. DataLabs, Rave.).
• Good knowledge of electronic source data capture systems (e.g. ClinBase).
• Good knowledge of all DB set- up activities including but not limited to Database Configuration Specifications, Data Validation.
• Fluent English.
• Basic knowledge of SAS.

go to method of application »

The Data Management Lead ll provides leadership and expertise in all aspects of Data Management. Develop and manage timelines for study data deliveries, including Go-Live, Interim Deliveries, and Final DB Lock. Collaboration with the relevant functions (Clinical, Biostatistics, Database Programming, Medical, Medical Writing etc.) across all geographies. Data Management’s single point of contact to ensure that the contracted Data Management deliverables are being met – specifically in terms of timeliness, financial management and quality.

The Data Management Lead ll works with minimal guidance from their Line Manager and/or Subject Matter Experts. DMLs may act as a mentor for ADMLs or other DML peers. May act as Project Leader for projects involving only Global Data Operations services.

Main Responsibilities

• Manage and coordinate the integration and utilization of all ancillary systems as appropriate
• Highlight issues/risks to delivery by understanding interdependencies. Define mitigations and drive to resolution with cross-functional stakeholders as part of Risk Management Plan
• Review and analyze metrics to derive meaningful summary of study health and trends
• Review of the Master Services/Service Level Agreement, and/or contract to manage toward sponsor-specific metric targets/Key Performance Indicators
• Host and attend cross-functional meetings. Prepare Meeting Agendas and Minutes, comply to action and decision logs
• Portray Parexel's technical and operational expertise and capabilities, and tailor to meet sponsor's specific needs
• Create relevant slides with cross-functional Global Data Operations input as appropriate
• Maintain inspection-ready Trial Master File
• Identification of quality issues, ensuring they are raised in relevant system and closed according to requirements
• Prepare for and participate in audits and inspections for internal, sponsor, and regulatory agencies
• Drive and implement Corrective/Preventive actions for study, and work toward alignment across Parexel as appropriate - share lessons learned across multiple projects within a program or therapeutic area
• Regular review and update of DM resources to ensure alignment with contracted budget, project resource forecast, actuals, and demand, utilizing the necessary systems and tools
• Determine and resolve the root cause of DM-related project variance in a timely manner, including negotiating/raising changes in scope

Ideal Candidate Will Possess

• Written and oral fluency in English
• Strong experience in clinical research industry
• Proven record of leading project and program teams
• Full understanding and application of relevant ICH-GCP Guidelines, local regulatory requirements and Parexel SOPs and study specific procedures
• Awareness of SDTM/CDISC/CDASH standards
• Strong technical skills including, but not limited to the knowledge of Clinical Trial/Data
• Management Systems (e.g. InForm, Rave, Veeva, DataLabs) and Microsoft Office products
• Strong ability to lead and collaborate with global teams. Motivate/guide virtual teams across multiple time zones and cultures to work effectively
• Strong interpersonal, oral and written communication skills using concise phrasing tailored for the audience with a diplomatic approach
• A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing environments
• Proficient presentation skills
• Customer focus to interact professionally and respectfully within Parexel and all external colleagues to build rapport and trust
• Proven problem-solving skills, including capability to make appropriate decisions in ambiguous situations, ability to conduct root cause analyses

go to method of application »

The Data Management Lead ll works with minimal guidance from their Line Manager and/or Subject Matter Experts. DMLs may act as a mentor for ADMLs or other DML peers. May act as Project Leader for projects involving only Global Data Operations services.

Main Responsibilities

• Manage and coordinate the integration and utilization of all ancillary systems as appropriate
• Highlight issues/risks to delivery by understanding interdependencies. Define mitigations and drive to resolution with cross-functional stakeholders as part of Risk Management Plan
• Review and analyze metrics to derive meaningful summary of study health and trends
• Review of the Master Services/Service Level Agreement, and/or contract to manage toward sponsor-specific metric targets/Key Performance Indicators
• Host and attend cross-functional meetings. Prepare Meeting Agendas and Minutes, comply to action and decision logs
• Portray Parexel's technical and operational expertise and capabilities, and tailor to meet sponsor's specific needs
• Create relevant slides with cross-functional Global Data Operations input as appropriate
• Maintain inspection-ready Trial Master File
• Identification of quality issues, ensuring they are raised in relevant system and closed according to requirements
• Prepare for and participate in audits and inspections for internal, sponsor, and regulatory agencies
• Drive and implement Corrective/Preventive actions for study, and work toward alignment across Parexel as appropriate - share lessons learned across multiple projects within a program or therapeutic area
• Regular review and update of DM resources to ensure alignment with contracted budget, project resource forecast, actuals, and demand, utilizing the necessary systems and tools
• Determine and resolve the root cause of DM-related project variance in a timely manner, including negotiating/raising changes in scope

Ideal Candidate Will Possess

• Written and oral fluency in English
• Strong experience in clinical research industry
• Proven record of leading project and program teams
• Full understanding and application of relevant ICH-GCP Guidelines, local regulatory requirements and Parexel SOPs and study specific procedures
• Awareness of SDTM/CDISC/CDASH standards
• Strong technical skills including, but not limited to the knowledge of Clinical Trial/Data
• Management Systems (e.g. InForm, Rave, Veeva, DataLabs) and Microsoft Office products
• Strong ability to lead and collaborate with global teams. Motivate/guide virtual teams across multiple time zones and cultures to work effectively
• Strong interpersonal, oral and written communication skills using concise phrasing tailored for the audience with a diplomatic approach
• A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing environments
• Proficient presentation skills
• Customer focus to interact professionally and respectfully within Parexel and all external colleagues to build rapport and trust
• Proven problem-solving skills, including capability to make appropriate decisions in ambiguous situations, ability to conduct root cause analyses

go to method of application »

What You Will Do

The Senior Clinical Data Analyst (SCDA) shall independently perform all clinical data cleaning activities on assigned FSP projects, commensurate with experience and/or project role. Further responsibilities shall include support on data processing activities and study level documents e.g. Protocol Deviation Specification, Data Validation specification, etc.

The SCDA may act as a Data Management Lead where required.

Key Accountabilities

• Assume the ability to meet the requirements of a CDA III roIe with a high degree of proficiency and autonomy.
• Lead/Responsible for data cleaning and data review activities e.g. query management.
• Management of project timelines (including creation, review and tracking of plans).
• Review of protocols and EDC Screens if required.
• Support data processing activities from database setup to database lock, e.g. SAE reconciliation.
• Perform user acceptance testing on study database setups.
• Perform medical coding on small studies.
• Track and review CRFs. Support data entry where required.
• Perform and or support the setup of DM documents and ensure proper documentation e.g. CRF Completion Guidelines (CCG)
• Perform/lead functional QC activities and testing.
• Mentor project team members.
• Be a subject matter expert when needed.

Ideal Candidate Will Possess

• Bachelor’s degree and / or other medical qualifications.
• Understanding of Global Data Operations tasks, specifically within Data Management and Database Programming and relevant data standards.
• Sound awareness of relevant regulations, including ICH-GCP, 21CRF11.
• Experience in clinical research.
• Good interpersonal, verbal and written communication skills.
• Knowledge of medical terminology and awareness of coding dictionaries (e.g.MedDRA & WHODRUG).
• Good knowledge of EDC systems (e.g. DataLabs, Rave.)
• Good knowledge of electronic source data capture systems (e.g. ClinBase).
• Good knowledge of all DB set-up activities including but not limited to Database Configuration. Specifications, Data Validation.
• Ability to work in team environment.
• Good analytical skills and attention to detail.
• Effective time management to meet daily metrics or team objectives, completion of assigned tasks in a timely manner.
• Basic knowledge of SAS.