TA Lead Manager
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, 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 Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
The TA Lead Manager is accountable for the management and timely delivery of all standards and governance related deliverables produced by Global Clinical Data Standards (GCDS) TA Leads under his/her supervision within the Global Data Management and Standards (GDMS) organization in collaboration with the Director, Delivery Management, Global Clinical Data Standards (GCDS).As the TA Lead Manager, the position is responsible for the development, implementation, and oversight of the standards project management framework and associated processes that drive end-to-end planning, delivery, and governance of standards components. The position is responsible for the management and supervision of GCDS Project Managers. The TA Lead Manager is also responsible for developing, mentoring, and providing leadership to staff under supervision.
Serves as a member of the GCDS Leadership Team, and proactively engages with stakeholders inside and outside of GCDS to ensure standards and governance delivery in adherence to applicable processes, procedures, standards, and clinical program requirements.
- Develops functional capabilities, and ensures achievement of performance targets aligned with organizational goals and objectives.
- In support of the Director, Delivery Management GCDS, ensures delivery alignment with established guidelines and targets.
- Drives timely, aligned delivery of standards and governance data management deliverables and services in support of Merck’s research pipeline.
- Manages employee performance, career development, and organizational talent and succession planning.
- Proactively engages with key customers and stakeholders on behalf of GCDS to recognize potential value-creating opportunities and to drive improvements in quality, efficiency, and productivity across the organization.
- Keeps abreast of project management, clinical data standards, including regulatory requirement for clinical data standards, technology and clinical data management disciplines; actively engages in industry forums
- Leads and participates in organizational initiatives as assigned
- Supports audits and inspections as required
- As a member of the GCDS Leadership Team, provides strategic and operational input into decisions impacting the direction and success of GCDS
- B.A. or B.S. degree, preferably in life sciences, information technology, or related discipline.
- Minimum of 7 years’ experience in Clinical Data Management (or related discipline)
- Minimum of 5 years’ experience implementing industry standards (e.g. Controlled Terminologies, CDISC CDASH, SDTM)
- Experience managing clinical data management processes including electronic Case Report Form (eCRF) design, clinical database development and validation, user acceptance testing, external data management, data extraction, and reporting
- Exceptional communication skills (oral and written), with the ability to communicate with both the technical and business functional areas
- Exceptional people and thought leadership skills, with the ability to think strategically and to influence others.
- Must have an innovative spirit, outstanding interpersonal skills, and demonstrated proficiency in the management of multiple projects.
- Knowledge of industry standard requirements for submission deliverables (e.g., SDRG, ADRG, Define.xml)
- Strong leadership and proven ability to drive results in a global, matrix environment
- Ability to effectively collaborate and problem solve across both business and technical functions
- Experience applying formal project management tools and processes
- Direct-line people management experience
Your role at Merck 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 Merck, we’re inventing for life.
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Job: Clinical Data Management
Other Locations: Boston, MA, US; Upper Gwynedd, PA, US
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Company Trade Name: Merck