Senior Local Trial Manager

Job Description

• Provide line management to direct reports and support GCO Head in setting goals and objectives, performance evaluation and talent development.
• Support GCO Head in evaluating and forecast resource needs for assigned portfolio and/or other specific area of responsibility, as required and agreed with local GCO management accordingly.
• Define, execute or support of long-term strategy in alignment with GCO, GCDO and Janssen R&D strategies to position the local and global GCO organization for success.
• Oversight of execution and monitoring of clinical trials through all phases ( from feasibility to closeout) and ensuring inspection-readiness within assigned therapeutic area(s) and/or other area of responsibility, as required.
• Ensure relevant operational objectives are met in conformance to ICH-GCP, relevant SOPs and other procedural documents.
• Accountable for appropriate and timely issue escalation and reporting (suspicion) of fraud, scientific/ethical misconduct and health care compliance breach. Contribute to CAPA and issue resolution in accordance with required timelines. Ensure adequate quality oversight within assigned therapeutic area(s) and/or other area of responsibility, as required.
• Shape and maintain strong relationships within local GCO department and Local Operating Company (particularly with Medical Affairs) and other key internal and external stakeholders.
• 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.
• Leads and coordinates local trial team activities in compliance with SOPs, other procedural documents and applicable regulations. Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
• Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.

• 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.
• Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations.
• Flexible mindset and ability to work in a fast-changing environment.
• Proficient in English language. Computer literacy. Strong interpersonal and negotiating skills.