Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Functional manager ED&CP, located in the UK.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
The Functional Manager (FM) Early Development and Clinical Pharmacology (ED&CP) position is accountable for the successful regional or country execution of all phases of clinical trials for an assigned Therapeutic Area(s) or specific role(s), including resource allocation, adherence to timelines and budget, compliance with all GCO SOPs, policies and regulatory requirements.
This position is responsible for the direct functional management of Local Trial Managers, Site Managers and Investigator Document Associates/Clinical Trial Assistants and other TCSM functions, where applicable. Oversees staff development, project assignments, workload distribution, and issue resolution with direct reports. This position has direct collaboration with Local R&D head, Regional Therapeutic Area Experts, CTC, Quality and Compliance staff and other internal/external business partners as required (i.e., Local Operating Company, Janssen R&D). Alignment of goals with organizational objectives as defined in the GCO local goals objectives.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
• Evaluates and projects resource needs for assigned portfolio, and liaises with local TCSM management for resource requests as appropriate.
• Strong interaction with Flex Resource managers to provide feedback on Flex Resource performance.
• Interviews, hires, develops and trains staff
- For employees: Responsible for performance and development in accordance with the Performance Management guidelines, including talent development, coaching, mentoring and providing ongoing performance assessment
• Ensures staff have a clear understanding and knowledge of GCO SOPs,Work Instructions and Company Policies supported by documentation.
• Ensures adequate, timely and compliant management of clinical studies through all phases of the trial- feasibility through database lock
• Ensures studies are in a constant state of inspection-readiness. Works with Quality Management (QM) Liaisons to ensure quality oversight of studies utilizing the available tools.
• Supports staff in communications with Ethics Committees, Health Authorities, Investigational Sites and groups external to GCO. Coaches staff in their role in local Health Authority site inspections and follow-up activities including CAPA generation.
• Conducts Accompanied Site Visits with Site Managers.
• Overall accountability for planning, executing and monitoring of clinical trials through all phases of the trial feasibility through database lock, and inspection-readiness for assigned Therapeutic Area or study portfolio in country or for TCSM activities of specific role (s).
• Appropriate and timely issue escalation to line management and study team as appropriate. Report (suspicion) of fraud or scientific/ethical misconduct.
• Strong interaction with the R&D/Local Operating Company staff and departments within GCO and outside of GCO, i.e., GCO Early Dev. & Clinical Pharmacology as applicable,, GCO Medical Affairs regional leadership, Central Trial Coordination (CTC), Integrated Data Services (IDS), Clinical Supplies Unit (CSU), Quality and Compliance (QC) and external vendor groups, Medical Affairs).
EDUCATION AND EXPERIENCE REQUIREMENTS
• Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
• Minimum of 5 years’ experience in the pharmaceutical industry, at a CRO or hospital including clinical research experience. ED&CP experience is desired
• Effective communication and leadership skills and ability to develop team productivity and cohesiveness.
• Experience mentoring/coaching others. Experience with people management is desirable. Ability to lead hiring, training, development and evaluation of people. Solid decision-making and financial management skills.
• Strong knowledge on drug development, clinical research operations and regulatory requirements including GXP, ICH and local regulations or FDA CFRs (if applicable). Strong ability to synthesize and evaluate data generated from various reports and sources.
• Proficient in English language. Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint). 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.
• Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United Kingdom-England-High Wycombe-
Janssen Cilag Ltd. (7360)
Clinical Trial Coordination