Job Description
The Senior Data Manager brings advanced understanding of the clinical data management process from study start‑up through database lock, including database design and data validation as per the requirements in the clinical study protocols, data review plan, & data management plan. The scope of this role may span multiple programs.
Responsibilities
- Responsible for end-to-end data management activities and vendor oversight activities across global development programs.
- Represents data management function on a client in-house Data Management model for all data related deliverables, especially in support of key decision points and regulatory submissions.
- Contributes influential leadership in collaboration with other client stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
- Partners with appropriate stakeholders to mitigate and resolve risks.
- Provides input to functional governance with client strategic suppliers. Partners with appropriate stakeholders to resolve issues escalated from the vendor and/or cross-functional teams.
- Participates in preparing the function for submission readiness and may represent function in a formal inspection or audit.
- Participates and represents function in formal inspections and audits as requested.
- Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
- Ensures achievement of major data management deliverables and milestones in coordination with other functions including Clinical Operations, Statistical Programming and Statistics.
- Acts as a process expert for data management operations and team oversight.
- Maintains SOPs, process maps and templates and timelines to support function’s operational models.
- May prepare metrics to support the function’s KPIs.
- Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best practice and increase the visibility of the client.
- Contributes or leads functional continuous improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.
- Ensure compliance with own learning curricula, corporate and/or GXP requirements.
- Works cross-functionally to ensure the quality of the data in each database and on‑time delivery, as well as the quality of other data management deliverables.
- Performs other duties as assigned.
Educational Qualifications
- MS or BS in a health‑related, life sciences area or technology‑related field.
Minimum Work Requirements
- Minimum of 7 years of data management and/or drug development experience with expertise in the cross‑functional interfaces with the data management function.
- Proven track record of strong project management skills and experience managing data management activities for large drug development programs.
- Experience with all phases of development in one or more therapeutic areas preferred.
- Ability to handle multiple development programs simultaneously.
- NDA/CTD experience preferred.
- Strong knowledge of data management best practices & technologies as applied to clinical trials.
- Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
- Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management processes.
- Advanced knowledge of broad drug development process with expertise in the cross‑functional interfaces with the data management function.
Special Skills
- Advanced knowledge of office software (Microsoft Office).
- Experience with budget planning & management.
- Experience in a CRO environment or client in‑house data management model.
- Strong knowledge of relational databases and experience using multiple clinical data management systems.
- Good working knowledge of general medical coding in the pharmaceutical/biotechnology industry, including knowledge of medical dictionaries, coding tools, and coding governance models.
- Preferred experience with Medidata RAVE and Elluminate/CDS/CDR.
- Ensures adherence to functional budget, and provides timely updates to manager regarding additional, potential spend or cost savings.
- Expert knowledge of CDISC standards, SDTM preferred. Good experience leading standards selection and implementing in clinical trials is ideal.
- Expert knowledge of general medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes.
Behavioral Competencies
- Pragmatic and willing to drive and support change.
- Comfortable with ambiguity.
- Able to influence without authority.
- Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.
- Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenges the status quo.
- Embody a culture of continual improvement and innovation; promotes knowledge sharing.
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