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.
- Reviews Monitoring Visits Reports and escalates performance issues and trainingneeds 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, 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)