Requisition ID: CLI008099
MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125:year legacy. MSD's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
The Global Data Operations Therapeutic Area Lead (GDO TA Lead) is responsible and accountable for the organization and strategic direction of a TA within GDO. Ensures that sound data management principles are incorporated into the clinical research programs conducted by GDO in support of in:scope studies within their TA. Ensures consistent, high quality and standard data management processes in their TA are complied with, as appropriate, and that processes meet worldwide regulatory guidelines and internal Standard Operators Procedures (SOPs). Performs within broad general policies and goals with minimal supervision. Responsibilities include interaction with individuals across multiple MSD functions and sites, including line management of GDO staff.
Primary Activities include, but are not limited to:
1.
All responsibilities of a GDO Program Lead (GDOPL), if needed.
2.
Alignment within assigned TA(s) of clinical data requirements.
3.
Leadership of GDO supported Data Management (DM) trial level and submission deliverables within their responsible TA(s).
4.
Partnering with the PDMS TA Head, CSSM (Clinical Sciences and Study Management) TA Heads, as well as other cross functional leaders as needed, to align cross functional strategy, operations and execution related to their responsible TA (s)
5.
Serving as GDO Point of Contact for engagement with Health Authorities during sponsor and site inspections related to trials within their TA(s).
6.
Aligning with GDO Regional Director of Operations (RDOs) around the organization, including strategic direction of assigned TA(s).
7.
Oversight of assigned portfolio:
Ensure compliance, quality, consistency and timeliness
Trend identification and management
Risk identification, management and communication
Forecasts short and long term resource needs
8.
Accountable for ensuring connectivity with Standards and TAST (Therapeutic Area Standards Team) across their TA(s).
9.
Aligns others around a positive direction. Under the guidance of the department head and/or their manager, develops high level, challenging, but achievable objectives that clearly support stated organizational goals.
10.
Establishes measures to improve their area's effectiveness and efficiency, and develops strategic plans.
11.
Develops career plans for direct reports, makes work assignments, conducts periodic skill assessments as well as annual performance appraisals, coaches for performance, provides ongoing feedback on performance, provides rewards and recognition, and sets priorities.
12. Provides consultation and expertise on data management or functional area:specific activities, including their TA(s), to internal (e.g., Clinical, Regulatory Affairs, BARDS, Human Resources) and external (e.g., clinical investigators, regulatory agencies, vendors) customers and stakeholders.
13. May collaborate with data management groups from other divisions, companies, and agencies to ensure the validity and effectiveness of data management techniques and processes.
14. Keeps abreast of new developments in the area of clinical data management, especially in their TA(s), across the industry.
15. May support any other project or perform any other data management task deemed appropriate by management.
Qualifications
Education: B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline.
Experience:
