Job Description
JOB DESCRIPTION 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.
RESPONSIBILITIES 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.
QUALIFICATIONS 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.
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.
Job Tags
Permanent employment, Work at office