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, e TMF 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.
Bachelor's Degree in Science, Biology or equivalent. An advanced degree would be advantageous (e.g., Master's degree, MD, Ph D).
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.
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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Regular
No relocation
Not Applicable
10/31/2024A 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.
Job skills required: Project Management, English, Research, Compliance
Job skills preferred: Biology