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. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
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Global Clinical Trial Operations (GCTO) is a global organization with over 5,400 people operating in (47) countries. GCTO is responsible and accountable for the execution of the Merck HQ clinical research portfolio, including clinical grants in excess of $1B.
The position of Regional Head for GCTO manages all aspects of clinical trial operations in their respective region and reports to the head of GCTO.
- Responsible for trial quality, compliance and effectiveness. The incumbent ensures a single point of contact for managing clinical trial execution in all its aspects across phases I/II through IV/V within the country/sub-region. The position has multiple touch points both externally with senior staff and executives in Merck Research Laboratories (MRL) and Global Human Health (GHH) / Global Medical Affairs (GMA) as well as externally to Merck.
- Responsible for managing Area Leads within countries including, recruitment, performance management, talent management and management decisions related to the regions organization. Estimates resource and budget needs, based on trial workload and manages this for the overall Region. Position is also a key member of the LT for the global clinical trial operations function and as such contributes significantly to global strategy for trial execution at Merck.
- Provide leadership to the Region. This includes continual optimization of the organizational design and resources, ownership and optimization of key processes, talent and succession management, overall operating budget management and oversight of all high priority programs and studies
- Manage Clinical Operations activities and personnel within the Region (Note: Not all positions in all regions), including the Regional Operating Center, Regional Country and Cluster Directors, and their respective staff. Ensure that compliance, quality and timeline objectives are met for all trials executed in the region.
- Collaborate with Functional Service Provider (FSP) Senior Leadership to ensure adequate and appropriate resourcing for the Merck internal clinical trial portfolio
- Collaborate with Clinical Research Organization (CRO) Senior Leadership to ensure the successful implementation of fully-outsourced clinical trials
- Work with the Global Operations group within GCTO and Global Medical Directors as appropriate, in site management and selection decisions. Provide input into protocol design, feasibility, and resource assessments as appropriate
- Support the development and management of Investigator relationships in conjunction with the MRL Therapy Areas and Human Health colleagues. Contribute to the program life-cycle management through effective study allocation and execution (prioritizing programs, working with KOLs, etc.).
- Take responsibility for any clinical audits, working closely with the Quality Assurance (QA) group or GQAC as appropriate.
- Represent GCTO and the Regions on strategic initiatives at all levels of the organization. Provide leadership to the GCTO organization as a member of the GCTO Senior Leadership Team. Effectively manage resources to ensure appropriately skilled and high performing staff members are assigned to support the effective execution of the portfolio and achieve Global Clinical Trial Operations, Global Clinical Development, and Merck Research Laboratories objectives. Sets clear performance standards and holds self and organization accountable for achieving results.
- Responsible for ensuring appropriate scientific and operational training for staff members.
The position can be located within the East Coast of the United States. Qualifications:
- Required: Masters degree in a Life Science combined with a long term successful job experience
- Preferred: MD, PhD, PharmD
- Minimum of (10) years r elevant experience in Clinical Operations
- Significant Management and Clinical Operations experience, with the ability to service different stakeholders in a matrix organization.
- Experience and understanding of various staff resourcing models as well as the related employment regulations within their respective countries.
- Strong understanding of local Health Authority requirements
- Proficient in English and have Intermediate to Expert proficiency in local languages as appropriate.
- 50% Travel
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Visa sponsorship is not available for this position.
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