Job Description

This position is responsible for project management of the assigned studies, accountable for performance for assigned protocols, leads local study teams to high performance on trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert etc.

Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines, and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

WHAT YOU WILL DO

Key Responsibilities:

• Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
• Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.

• Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

  • Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
  • Performs Quality control visits as required.
• Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTC, CRAs and COM).
• Responsible for creating and executing a local risk management plan for assigned studies.
• Ensures compliance with CTMS, eTMF and other key systems in assigned studies.
• Escalates as needed different challenges and issues to TA Head/CRD/CCQM and or CTT (as appropriate).
• Identifies and shares best practices across clinical trials, countries, clusters.
• Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
• Country POC for programmatically outsourced trials for assigned protocols.
• As a customer-facing role, this position will build business relationships and represent company with investigators.
• Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets).
• Supports local and regional strategy development consistent with long‐term corporate needs in conjunction with CRD, TAH and Regional Operations.
• Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Global Medical Affairs to align on key issues/decisions across the trials. Consult with GHH as needed

WHAT YOU MUST HAVE

To be successful in this role, you will have strong technical skills as well as business capabilities. The requirements are as follows:

• Bachelor's Degree in Science, Biology or equivalent. An advanced degree would be advantageous (e.g., Master's degree, MD, PhD)
• Minimum of 5 years' experience in clinical research
• Knowledge in project management, site management and team management.
• Strong organizational skills with demonstrated success required.
• Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight, and supervision of the TA Head or CRD
• Requires strong understanding of local regulatory environment.
• Strong scientific and clinical research knowledge is required.
• Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
• Experience functioning as a key link between Country Operations and Clinical Trial Teams
• Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures, and functions.
• Ability and skills to manage resource allocation, processes (and controls), productivity, quality, and project delivery.
• Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.
• Strategic thinking. Ability to work efficiently in a remote and virtual environment.
• Understand cultural diversity.
• The position requires proven strong project management skills and/or project management certification or relevant training program/close mentoring. Behavioral Competency Expectations: Strong leadership skills that enable and drive alignment with the goals, purpose, and mission of our Research & Development Division , Global Clinical Development (GCD) and GCTO.
• Ability to identify problems, conflicts, and opportunities early and lead, analyze and prepare mitigation plans and drive conflict resolution is critical.

• Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruption. Examples of common problems include:

  • low patient recruitment,
  • inadequate staff to meet business needs,
  • performance or compliance issues,
  • working with regulatory issues and the broader organization
  • resolution of conflictive situations.

• Educational/pedagogic, diplomatic, and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

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Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

10/31/2024

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
  

Requisition ID:R316640