Associate Clinical Research Manager
2 weeks ago
With support of other Clinical Research Managers and/or Therapeutic Area Head/Clinical Research Director, this role is 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.
The Associate Clinical Research Manager could be responsible for a particular study for a country or a cluster.Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation.
Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
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).
- Responsible for project management of the assigned studies: proactively 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 Clinical Research Associate 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 Clinical Research Associates 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 eTMF and other key systems in assigned studies.
- Escalates as needed different challenges and issues to Therapeutic Area Head/ Clinical Research Director/Country Clinical Quality Manager.
- Identifies and shares best practices.
- Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
- As a customerfacing role, this position will build business relationships and represent our Company with investigators.
- Supports local and regional strategy development consistent with long‐term corporate needs in conjunction with Clinical Research Director, Therapeutic Area Head and Regional Operations.
- Collaborates internally with Headquarter functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Regulatory Affairs, Global Medical and Scientific Affairs to align on key issues/decisions across the trials. Consult with Human Health as needed.
Qualifications, Skills & Experience
Skills:
- Knowledge in Project Management and/or site management.
- Strong organizational skills with demonstrated success in related role or discipline 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 understanding of local regulatory environment.
- Scientific and clinical research knowledge is required.
- Understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
- Ability to function 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 to manage 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.
- Aptitude for building leadership skills that enable and drive alignment with the goals, purpose and mission.
- Ability to identify problems, conflicts and opportunities early, analyses 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:
1) low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or compliance issues, and 5) resolution of conflictive situations.
- Understand cultural diversity.
- Stron
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