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Gdo Program Lead

hace 1 mes

Bogotá, Bogotá D.E., Colombia MSD A tiempo completo

Job Description:


In support of, and supported by, the GDO TA Lead, the GDO Program Lead (GDO PL) oversees the successful execution of the clinical data management strategy for one or more drug, biologic or vaccine programs/indications.

Accountable for ensuring GDO deliverables are available for all clinical trial milestones for in-scope trials.

Ensures all aspects of the GDO specific sections of the project plan (from protocol planning through data management submission components) are executed on time and with the highest quality.

Coordinates and aligns deliverables of Lead Clinical Data Managers (LCDMs) working at the trial level within assigned programs/indications.

Acts as the single point of contact for GDO at the program/indication level, including representing GDO on cross-functional program teams as needed, as well as other program-level development forums.

Mentors, guides, and provides project leadership for junior staff, as assigned. Line Manager of GDO staff.

Primary Activities include, but are not limited to:

Oversees the data management strategy and project plans within GDO for collection and integration of all clinical data (including, but not limited to, case report form (CRF) data, lab data, biomarker data, and patient reported outcomes, etc.) for one or more programs/indications.

In collaboration with PDMS PM, partners with functional area representatives to ensure appropriate use of database standards and program-level consistency on database, data collection, review, and retrieval specifications.

Monitors the Book of Business (BoB) and program-specific clinical development plan(s) (both continually and timely) to initiate GDO resourcing and activities.

Provides program-related oversight and guidance to LCDMs, and ensures quality and consistency of GDO requirements and deliverables, through archival, across trials within a program/indication.

Uses excellent interpersonal, negotiating, and project management skills to perform the following tasks:

  • Project plan review/input, execution, and change control related to GDO responsible sections
  • Project team development and resource planning within GDO
  • Risk management (i.e., risk identification, analysis, and response planning, as well as risk monitoring and control), including engagement with GDO TA leads, PDMS PMs and functional leadership for issue resolution and escalation as necessary
  • Communications planning, information distribution, performance reporting, and project closure within GDO teams
  • Management of customer/stakeholder expectations; participation in crossfunctional decisions


Keeps abreast of industry information and changes related to Pharma DM through interaction with experts both within and outside of MSD.

Identifies and develops improvements to data collection and data management processes and tools. Supports audits and inspections within program/indication, as necessary. May lead continuous improvement special projects, or any other data management task deemed appropriate by management. May serve as LCDM for one or more trials within assigned programs, if needed.

Education:
B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline.

Experience:

At least 4 years' experience in Clinical Trials

At least 1 year experience in People Management or equivalent demonstrated leadership

Knowledge and Skills:

Knowledge of the E2E clinical development process

Demonstrated leadership and project management skills

Strong organizational, communication, negotiating and problem-solving skills

Search Firm Representatives Please Read Carefully

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:
R221159

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