Johnson & Johnson Careers
Clinical Research Manager, Oncology
Requisition ID: 1905762969W
The Clinical Research Manager (CRM) reports to the UK Clinical R&D Director, and is accountable for successful execution of the UK arm of phase Ib-IIIb clinical trials within the Solid Oncology therapeutic area. This includes resource allocation, adherence to timelines and budget, compliance with Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and local regulatory requirements. With the other CRM's, supporting the Director define the local clinical operations strategy to ensure its optimal efficiency and be ready for the future.
You will be line managing Local Trial Managers (LTM), Site Managers (SM), Clinical Trial Assistants (CTA) and/or other GCO staff, as required. The role has a strong focus on staff performance, people development and training and workload distribution. Ensuring alignment of the goals with organizational objectives (both medical and clinical operations). By finding creative solutions and process improvements, enabling the UK to continue to play a meaningful role in Janssen clinical research.
- Provide line management to direct reports including setting goals and objectives, performance evaluation and talent development.
- Evaluate and forecast resource needs for the oncology clinical trial portfolio.
- Support the flexible resourcing model and collaborate with flex resource managers to get qualified staff, providing recommendations on flex staff performance and support their on-boarding and off-boarding.
- Ensuring understanding of clinical trial processes and procedural documents supported by documentation of direct reports’ training compliance, as required.
- Supporting direct reports in issue resolution and communication with involved partners.
- Championing an environment that inspires sharing of ideas, information and standard methodologies (internal /external to the organization).
- Coaching and mentoring team members as needed, including conduct of accompanied site visits as appropriate.
- Supporting execution of long-term strategy in alignment with Global Clinical Development Operations (GCDO) to position the UK for success.
- Overseeing execution and monitoring of clinical trials through all phases (from feasibility to close-out) and ensuring inspection-readiness.
- Ensuring relevant operational objectives are met in conformance to ICH-GCP, relevant SOPs and other procedural documents.
- Accountability for appropriate and timely issue reporting (suspicion) of fraud, scientific/ethical misconduct and HCC breach. Contributing to CAPA and issue resolution in accordance with required timelines.
- Shaping and maintaining positive relationships within local GCO department and Local Operating Company (particularly with Medical Affairs) and other key Partners.
- Developing country capabilities for an effective study placement within your therapeutic area(s)
- Accountable for robust feasibility process and oversight of site selection to deliver on country commitments and strategic goals.
- Contributing to development, evaluation and implementation of new processes and systems to improve study management.
- Ensuring adequate quality oversight within assigned therapeutic area(s) and/or other area of responsibility, as required.
- Cultivating a culture of continuous improvement and innovation within the local GCO team.
Do you have the following Education and Experience we are looking for?
- Bachelor's degree or equivalent, 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.
- Previous line management experience (medium to large size team) preferred.
- Proven financial management and decision-making and skills.
- Experience in mentoring/coaching others
- Skilled in leading, hiring, training, developing and evaluating people.
- Ability to generate and implement contingency plans for both productivity and quality issues when required.
- Excellent knowledge of drug development, clinical research operations and UK regulatory requirements including ICH-GCP, HCC and applicable regulations.
- Proven skills in effective communication with various partners (e.g. investigational sites, ethics committees, health authorities, etc.).
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, 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