The Global Clinical Operations (GCO) Functional Manager is accountable for strategic and operational management and successful country execution of all phases of clinical trials within assigned therapeutic area(s) or specific role(s), including resource allocation, adherence to timelines and budget, compliance with relevant Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and local regulatory requirements. The FM I supports the Local R&D Head in shaping and managing local organizational structure to ensure its optimal efficiency and demonstrates effective issue management.
GCO Functional Manager is responsible for line management of Local Trial Managers (LTMs), Site Managers (SMs), Clinical Trial Assistants and/or other GCO staff, as required. Oversees staff performance, development, training, project assignments, workload distribution and supports issue resolution with direct reports. Ensures alignment of local goals with organizational objectives. Drives innovative solutions and process improvements for the assigned therapeutic area(s), country and GCO/ Global Clinical Development Organization (GCDO) overall.
Provide line management to direct reports including setting goals and objectives, performance evaluation and talent development.
Interview, hire, develop and train staff. Evaluate and forecast resource needs for assigned portfolio and/or other specific area of responsibility,
Oversight of execution and monitoring of clinical trials through all phases (from feasibility to close-out) and ensuring inspection-readiness within assigned therapeutic area(s) and/or other area of responsibility, as required.
Develop country capabilities for an effective study placement within assigned therapeutic area(s) and/or other area of responsibility, as required.
Accountable for robust feasibility process and oversight of site selection to deliver on country commitments within assigned therapeutic area(s) and strategic goals.
Foster a culture of continuous improvement and innovation within the local GCO team.
Primary Reporting Structure: Reports to Director Functional Management or Local R&D Head
Primary interfaces: Local Trial managers, Site Managers, Clinical Trial Assistants, Local R&D Head, other Functional Managers, Global Product Lead/Global Trial Lead, Regional Therapeutic Area Lead and supporting roles in the country Qualifications
Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
Minimum of 5 years of clinical research experience acquired in pharmaceutical industry, CRO or investigational site.
Effective communication and leadership skills. Ability to foster team productivity and cohesiveness.
Experience in mentoring/coaching others (line management experience desirable). Skilled in leading, hiring, training, developing and evaluating people. Solid decision-making and financial management skills.
Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues when required. Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations. Ability to synthesize and evaluate data generated from various reports and sources. Demonstrated skills in effective communication with various internal and external partners (e.g. investigational sites, ethics committees, health authorities, etc.).
Flexible mindset and ability to work in a fast-changing environment. Operates under limited supervision.
Proficient in English language. Computer literacy. Strong interpersonal and negotiating skills. Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner.
France-Haute-de-Seine-Issy Les MoulineauxOrganisation
Janssen Cilag S.A.S. (7825)Fonction
Clinical Trial AdministrationRequisition ID