Job Description
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.
Our Clinical Research team pushes the boundaries of global healthcare through research and innovation. Through clinical trials, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
At the Country Operations level, the CRM has a significant impact on the ability to effectively conduct clinical studies and develop the pipeline of our company, while maintaining local regulatory and compliance requirements.
This role will be accountable for the end to end (from feasibility to close out) performance and execution of the clinical trials for assigned protocols, under the oversight of the Country Lead, and will ensure excellent study performance with strict adherence to local regulations, our SOPs and ICH GCP.
The role will work at country level with local stakeholders such as GMA, GHH, PV, and Regulatory and Regional and Headquarters stakeholders in GCTO to ensure alignment and development of the country capabilities in collaboration with the Country Lead and/or CRD.
Responsibilities include, but are not limited to:
Accountable for the successful execution, enrollment, and quality of their clinical trials.
Accountable to ensure timelines and key milestones are met in assigned clinical trials.
Point of Contact for CO and works closely for assigned protocols with HQ & GCD regional team.
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.
Collaborates with CL and/or CRD in order to develop and build territory of principal investigators and sites.
Responsible for quality and compliance in assigned protocols in country.
Performs quality control visits. Reviews Monitoring Visits Reports and escalates performance issues and training needs to functional vendor and internal management as needed. Oversees CRAs in collaboration with PLM.
Collaborates externally with investigators, regulators, and vendors.
Supports strategic initiatives across Global Clinical Development GCD and GCTO.
Travelling up to 50% of working time.
Qualifications Required:
Clinical Research 5-6 years' experience is essential.
CRA experience.
Master in science (or comparable); advanced degree (MD, PhD) possible but not required.
8-10 years of experience for a MS/MBA/JD in Pharmaceutical Industry.
3-6 years for an MD-PhD in Pharmaceutical Industry.
Core Competency Expectations:
Strong leadership skills that enable and drive alignment with the goals, purpose, and mission of Global Clinical Trials Operations.
As a customer-facing role, this position will build business relationships and represent our company with investigators.
Decision Making and Strategic thinking.
Impact on the ability to effectively conduct clinical trials and develop pipeline.
Ability to think cross-functionally and work across boundaries internationally.
Ability to identify problems, conflicts, and opportunities early and lead, analyze mitigation plans and drive conflict resolution is critical.
Fluent in Local Language and business proficient in English (verbal and written) and excellent communication skills.
Strong scientific and clinical research knowledge is required.
Strong ICH-GCP knowledge and proven strong project management skills and/or project management certification or relevant training program/close mentoring.
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