Job Description
This role is primarily accountable for the end-to-end performance and project management forassigned 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. Provide
a key support role to TA-Head / CRD to effectively manage team, volume of clinical trials, and local/regional or global projects. The Sr. CRM (Senior Clinical Research Manager) may be responsible for managing a specific study for several countries within a cluster.
Responsibilities include, but are not limited to:
• Main Point of Contact (POC) for assigned protocols and link between Country Operations and Clinical Trial Team (CTT).
• May support TA-Head / CRD with oversight of Therapeutic Area program(s) and strategy alignment as needed.
• Responsible for project management of the assigned studies: pro-actively plans, drives andtracks 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 andadverse event reporting requirements internally and externally.
o Reviews Monitoring Visits Reports and escalates performance issues and trainingneeds to CRA-Manager and/or functional vendor and internal management as needed.
o 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 CTCs, CRAs and COMs).
• 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.
• May act as a mentor.
• Responsible for collaboration with functional outsourcing vendors, investigators, otherexternal 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 our company with investigators and medical centers.
• 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, TA-Head 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 Global Human Health BU as needed.
Qualifications, Skills & Experience
Skills:
• Expertise in project and site management. The position requires demonstrated successful implementation of project management skills at program and site level.
• 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 andcommitments.
• Requires a complete understanding of ICH GCP and global/regional/local regulatory environment.
• Strong scientific and clinical research knowledge is required. Including extensive knowledge of regional and/or country clinical trial landscape.
• Deep understanding of the organizational structure of our R&D Department and cross-functional roles and responsibilities of its members.
• Strong understanding of clinical trial planning, management and metrics is essential aswell as the ability to focus on multiple deliverables and execute complex protocols simultaneously.
• Experience functioning as a key link between Country Operations and Clinical Trial Teams.
• Communicates effectively and fosters a collaborative spirit in a remote/virtual environmentand across countries, cultures and functions.
• Ability, experience, and skills to proactively manage resource allocation, processes (and controls), productivity,quality and project and/or program delivery.
• Oversee TA strategy alignment and consolidate relevant information, within specific indications, escalating to the TA-H / CRD accordingly.
• 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.
• The position requires proven strong project management skills and/or project management certification or relevant training program/close mentoring.
• High emotional intelligence
• Ability to focus on multiple deliverables and protocols/projects simultaneously.
• Exercise strategic thinking and executes effectively across projects
• Fosters understanding of cultural diversity.
• Strong leadership skills that enable and drive alignment with the goals, purpose and mission of our R&D Department, Global Clinical Development and Global Clinical Trial Operations.
• Ability to identify problems, conflicts and opportunities early and lead, analyze and creatively 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:
1) low patient recruitment,
2) inadequate staff to meet business needs,
3) performance or compliance issues,
4) working with regulatory issues and the broader organization, and
5) resolution of conflictive situations.
• Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders.
Qualification & Experience:
Required:
• 10+ years of experience in clinical research with demonstrated success
and increasing responsibilities of which 5+ years consisted of leading projects
• Bachelor degree in Science (or comparable)
Preferred:
• CRA Experience preferred
• Advanced degree, (e.g., Master degree, MD, PhD)
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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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
