Job Description
Under the direction of the applicable management, the Principal Clinical Data Manager (PCDM) is responsible and accountable for ensuring quality and consistent end-to-end data management deliverables which can include trial and standards level data collection specification authoring. He/she is also accountable for providing comprehensive technical guidance and design specific recommendations to the Lead Clinical Data Managers (LCDMs) when appropriate. The PCDM is able to work independently or within a team or as a team leader with equal effectiveness. They will interact with staff across our Company's sites and serve in the role of mentoring, guiding, and providing project leadership for LCDMs as assigned.
Primary activities include, but are not limited to:
- All required activities outlined in the Lead Clinical Data Manager (LCDM) job description at the discretion and direction of management.
- Helps ensure quality and consistency of data management requirements, specifications and/or deliverables across trials and across therapy areas. This may include, but is not limited to:
- Data Collection and/or data validation specification authoring and/or consultation.
- End-to-end review of design/data validation specifications consistent with: Protocol requirements, Therapeutic Area (TA) needs and data requirements.
- Subject Matter Expert (SME) level peer review/quality checks of specification documents and other deliverables.
- Provides process and technical related recommendations and guidance to LCDMs.
- Supports LCDMs via consultancy and teaching by example and review as well as mentoring as needed.
- May be expected to partner with functional area representatives to ensure:
- Appropriate use of database standards.
- TA/program-level consistency related to database development specifications, data collection guidance and needs, and data validation requirements and tools, including external data in support of the GDO TA lead.
- Keeps abreast of end-to-end clinical data management processes, procedures, trends and regulations through interaction with stakeholders and experts both within and outside of our Company across the industry.
- Identifies and develops areas for improvement in data management processes, standards and tools.
- May lead continuous improvement special projects, or any other data management tasks deemed appropriate by management.
- Primary leadership and oversight of all GDO Standards related roles, responsibilities and activities including but not limited to:
- GDMS Standards Review Committee representation and full engagement with GCDS.
- GDO Standards Committee & GDO TAST Governance & Leadership, including quality, efficiency, effectiveness, and resourcing.
- GDO Standards Training Program development, implementation and continuous maintenance.
- Primary Standards SME for all GDO processes involving standards activities.
- May serve as line manager for up to 4 direct reports.
Education: B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline.
Experience: Requires at least 3 years’ experience in Clinical Trial Data Management field or at least 5 years’ experience in Pharmaceutical and/or medical or research related field.
Knowledge and Skills:
- Thorough knowledge of end-to-end clinical data management and clinical development process.
- Process oriented with QC/QA profile, technical expertise, standards, preferably with CDISC/SDTM knowledge.
- Demonstrated strong leadership and project management skills.
- Ability to be flexible, to multi-task and work independently.
- Strong organizational, communication, and problem-solving skills.
- Ability to establish and maintain good working relationships with the different functional areas and work cross-functionally as part of a team.
Who we are …
For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
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