What are the responsibilities and job description for the Senior Global Manager, Site Start-up Lead position at Clark Davis Associates?
Contract – Senior Global Manager, Site Start-up Lead
Onsite, Basking Ridge area, NJ
Summary:
We are currently working with a client in the area in need of a Contract Senior Global Manager, Site Start-Up Lead. This role is responsible for the global execution of site activation for complex, high profile clinical trials to ensure efficient and compliant processes aligned with SOPs, ICH-GCP guidelines, and industry standards. Will partner closely with cross-functional teams and CRO’s to balance strategic oversight with leadership to address challenges and deliver study objectives. Will also develop site activation projections, mitigates risks impacting site activation, and monitors CRO performance by analyzing metrics.
This includes leading all aspects of site start-up activities, including fast-track initiation, milestone tracking, and document collection, while ensuring timely submissions and leveraging country intelligence for informed decision-making. This person will also be responsible for direct line management and supporting development of their team.
Responsibilities:
Develop the site start up strategy for each study assigned (complex, high profile), outlining all dependencies impacting site activation and actively mitigating and escalating risks.
Oversee the tracking and analysis of study metrics, including risks and mitigation strategies and to evaluate CRO performance and implement corrective actions.
Advocate for optimized site selection strategies, leveraging data-driven insights to guide cross-functional teams toward effective decision-making.
Lead the development, assessment, and alignment of site activation projections, ensuring cross-functional and CRO collaboration to meet strategic objectives.
Ensure comprehensive and compliant documentation of site start-up materials in the Trial Master File (TMF) to maintain inspection readiness.
Partner with cross functional and CRO partners (where applicable) to develop a comprehensive global country start up strategy, outlining all dependencies impacting country start up and actively mitigating and escalating risks cross functionally.
Monitor and maintain country intelligence data to support informed decision-making and develop accurate startup projections and strategic plans.
Support regulatory submissions as needed, including activities such as: providing required site documentation, coordinating submissions to Central Institutional Review Boards (CIRBs), supporting sites with Local Institutional Review Board (LIRB) submissions, and handling or supervising Clinical Research Organization (CRO) insurance requests, etc.
Ensure timely country submission deliverables (ensure task completion; all roles clarity, identification of critical path items, effective communication pathway).
Lead and oversee all aspects of site start-up activities for complex, high profile studies, including fast-track site initiation, site calls, document collection, and milestone tracking, ensuring timely and efficient completion of processes.
Serve as the subject matter expert for essential site documents, providing training, guidance, and support to teams and sites on regulatory requirements, document management, and TMF filing.
Oversee CRO site start up management or in house site facing regional Study Start up team, where applicable
Lead the collection and analysis of site intelligence to support strategic site selection and site start-up.
Oversee the preparation and approval of site regulatory package, ensuring compliance with country-specific requirements, TMF standards, and ICH-GCP guidelines, while supporting inspection readiness and maintaining high-quality site documentation.
Represent Study start up on cross-functional teams, providing updates, escalating challenges, and proposing mitigation strategies for site start-up issues.
Act as the escalation point for CRO and internal team to ensure timely Study start up issue resolution.
Recommends and drives cross functional and department process improvements.
Responsible for direct supervision of staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight.
Required:
Must have strong Biotech/Pharma or CRO industry experience, minimum 5 years.
Experience with Trial Master File (TMF)
Global Site Activation & Global Study Start up experience