Senior Clinical Data Manager

The Senior Data Manager

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.

Key responsibilities may include:

• 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 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 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 quality of other data management deliverables   

• Performs other duties as assigned.

Educational qualifications:

• MS or BS in health-related, life sciences area or technology-related field.

Minimum Work Requirements:

• Minimum of 7 years data management and/or drug development process 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.

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Behavioral Competencies:

• Pragmatic and willing to drive and support change.

• Is 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; challenge the status quo.

• Embody a culture of continual improvement and innovation; promote knowledge sharing.