Global Trial Leader
Our client is looking for an experienced Global Trial Leader with a background in study management and project management to support global, complex Oncology trials. This person will be responsible for leading cross-functional teams, driving forward all strategic trial-related initiatives, identifying and mitigating risks, and communicating with key partners and stakeholders. We are looking for this person to be a great team player, a leader, and a creative thinker.
· Lead the cross-functional Trial Team in tracking and managing Project Deliverables, milestones, and timelines.
· Identify risks and ensure mitigation and contingencies are being initiated and followed through (including management of CAPAs).
· Ensure regional/global clinical operations deliverables progress according to agreed-upon timelines and milestones as leader of the Study Management.
· Ensure that protocol feasibility and country and site selection processes are conducted within timelines.
· Ensure trial related issues (quality, timelines, budget, resources) are resolved within the function. Manage timely and accurate documentation of issue escalation.
· Develop the trial ESP strategy for assigned trial in line with the overall program ESP strategy. Accountable for oversight of all external service providers used for the trial for both inhouse and outsourced studies.
· Report information to relevant key stakeholders.
· Ensures Trial Team members have received the appropriate trial-specific training needed for their function. Oversee the set-up and coordination of Investigator Meetings, if applicable.
· Ensures Trial is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes.
· Creates 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 Escalation processes, External Service Provider Oversight Plan, Filing and Archiving Plan.
· Cross-functionally interact with the Therapeutic Area, Clinical Supply Chain, Bioresearch Quality and Compliance Group, Clinical Business Operations, Finance, Project Management Organization, Clinical Pharmacology, and external partners to influence alignment on issues and decisions affecting trial management, enabling successful trial outcome.
· Accountable for delivery of global trials within agreed/projected life of trial budget. Ensures accurate trial budget management, updates for scope changes and reconciliation of assigned trials for both Out of Pocket (OOP) costs and FTE costs.
· Minimum 10 years of clinical operations experience, inclusive of at least 3 years of experience in global trial management from feasibility through close out.
· Experience tracking and managing timelines, milestones, and budgets, overseeing risks and mitigations, creating study-specific documents, and developing overall trial strategies.
· Experience working in early clinical development, specifically Phase I and II.
· Demonstrate deep knowledge of protocol and procedures and adequate therapeutic area knowledge.
· Bachelor’s Degree required.
· Experience working in Oncology and/or Immunology preferred.
· Experience working in Medical Device development preferred.
· Demonstrated ability to lead, learn quickly, work independently as well as collaboratively on a team, and adapt in a fast-paced, highly productive environment
Medasource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.