Website Johnson & Johnson
The Global Trial Leader (GTL) will have primary global accountability at the trial level within the Global Development (GD) organization. The GTL will provide operational expertise for the successful cross-functional delivery of assigned early development clinical trial(s), within agreed timelines and budget, and in alignment with all the applicable Standard Operating Procedures (SOPs) and regulatory requirements.
- Develop the trial ESP strategy for the assigned trial in line with the overall program ESP strategy.
- Overall trial budget and contract management, including updates for scope changes, review and approval of ESP contracts, change orders and ensure services are delivered.
- Lead the cross-functional Trial Team (including GD and non-GD members) and collaborate with all trial team members, building the trial operational plan, in alignment with the organizational and the Therapeutic Area (TA) Clinical Team’s objectives. Define risk mitigation strategies and ensure implementation thereof.
- Maintain oversight of the trial by taking an operational leadership role in a matrix organization, which includes coordinating activities in the Trial Team and ensuring ad-hoc trial Working
- Groups are organized as needed, driving issue identification and resolution, contingency planning, and decision-making.
- Build and update study-specific documents, such as Monitoring Guidelines, Informed Consent Form, IMP related documentation, Blinding Plan, country and site feasibility related documents, Safety related documents, Protocol Deviations and Issue processes, ESP Oversight Plan, Filing and Archiving Plan.
- Participate in preparation for, Health Authority inspections and internal QA audits.
- Drive the final study placement and ensure alignment with and communication to the involved partners, including TA and regional GCO TA experts.
- Identify risks and ensure mitigation and contingencies are being initiated and followed through (including management of Corrective and Preventive Action Plans).
- Oversight of external service providers (ESP), including ESP contracts and budgets. In addition, this individual will be involved in planning and execution of both internally managed and outsourced trials, with scope from draft protocol elements document to availability of the Clinical Study Report and applicable disclosure of the trial results.
- Drive lessons learned initiatives at trial level during and after trial achievement completion. Develop subsequent issue resolution and process improvements as required.
- Contract Research Organization (CRO) management, including initiation of selection process, Statement of Work (SOW) development, budget and change orders and oversight of all deliverables outsourced to the CRO.
- A minimum of 8 years of clinical trial experience within the Pharmaceutical industry or Contract Research Organization (CRO) is required.
- A minimum of a Bachelor’s or equivalent University degree is required, preferably in a scientific discipline (e.g. Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
- Must have strong people leadership skills.
- Experience in the Oncology Therapeutic Area is preferred.
- Must have strong communication skills.
- Experience with vendor management is required.
- The ability to lead all aspects of execution of a clinical trial is required.
- An exploratory scientific mindset with focus on disease area and Pharmacokinetics/biomarkers is preferred.
- Clinical trial experience in Early Development and Late Development is preferred.
- The ability to collaborate with all levels and influencing decision-making in a global, matrix environment is required.
Company: Johnson & Johnson
Vacancy Type: Full Time
Job Location: Raritan, NJ, US
Application Deadline: N/A