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.
MSD’s Regulatory Affairs division helps bring new medical
advancements to the world by facilitating the communications and procedures
that allow swift, organized compliance across regulatory agencies. As a team of
energetic, results-driven individuals, we’re a global network on the
leading-edge of healthcare breakthroughs that help provide new, reliable, and
compliant medical products, practices, and solutions to the world on time,
Oversees the data management strategy and project plans 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 for one or more development programs. Works with a cross-functional team across multiple sites to ensure that all aspects of the project plan (from protocol planning through data management submission components) are executed on time and with appropriate quality. Partners with functional area representatives to ensure appropriate use of database standards and project-level consistency on database, data collection, review, and retrieval specifications.
Serves as project manager of all clinical data management activities for protocols and/or compounds as assigned. Uses excellent interpersonal, negotiating, and project management skills to perform the following tasks:
- Project plan development, execution, and change control
- Project team development, resource planning, and cost estimating
- Risk management
- Communications planning, information distribution, performance reporting, and project closure
Provides direction for integrating external teams into the data management processes and ensures that data from disparate sources and database structures align with the clinical data management strategy.
Participates in the development of, and ensures adherence to, Merck clinical and regulatory data management standards.
Mentors, guides, and provides project leadership for junior staff as assigned.
Keeps abreast of project and clinical data management disciplines through interaction with experts both within and outside of the company.
May lead continuous improvement special projects, or perform any other data management tasks deemed appropriate by management.
- Bachelor's degree, preferably in life sciences, computer science, or related discipline.
- At least 6 years’ experience in Clinical Data Management;
- Full life-cycle experience in clinical data management (data collection system development through database lock and close-out);
- At least 3 years’ experience working with project management tools and processes;
- At least 2 years' experience/exposure working in Oncology Therapeutic Area.
- Knowledge of the clinical development process with in-depth knowledge of the Clinical Data Management lifecycle through submission deliverables.
- Able to work independently and as a member of team with equal effectiveness. 3. Demonstrated team leadership and project management skills.
- Proven strong organizational and problem-solving skills.
- Proven effective communication skills both orally and written with both technical and business areas.
Your role at MSD
is integral to helping the world meet new breakthroughs that affect generations
to come, and we’re counting on your skills and inventiveness to help make
meaningful contributions to global medical advancement. At MSD, we’re inventing
If you need an
accommodation for the application process please email us at staffingaadar@MSD.com.
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Primary Location: LATAM-Argentina-Buenos Aires-Vicente López
Job Type: Full Time
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Relocation Provided: None
Company Trade Name:MSD
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