Senior Sr. Manager

1 month ago

Rahway, United States Merck Sharp & Dohme Corp. Full time

Job Description

Global Clinical Trial Operations

This role is primarily accountable for the end-to-end performance and project management 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. 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 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 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, 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 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 and commitments.
  • 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 as well 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 environment and 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.
  • 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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