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Position Summary:

The successful candidate will oversee clinical trial activities, ensuring timely completion of deliverables by managing and coordinating with CROs, adhering to timelines, and maintaining budget control. This role requires independent management of internal study teams and outsourced activities, including study start-up, monitoring, site management, TMF, laboratories, drug supply, and data management. Additionally, the candidate will contribute to biostatistics, medical writing, safety, regulatory affairs, and quality assurance as needed. Close interaction with investigators and site staff through routine calls and site sponsor visits is also essential.

Responsibilities:

• Effectively manage global clinical studies or multiple studies within a clinical development program.

• Oversee study teams for assigned studies or programs and maintain relationships with CROs, central labs, IRBs, investigative sites, and other external partners.

• Coordinate activities of all trial conduct partners and team members, proactively identifying and managing risks.

• Participate in the development and review of supporting documents for clinical studies, registries, or access programs, including Protocols, Informed Consent Forms, Investigator Brochures, Study Manuals, Statistical Analysis Plans, CRFs, Data Management Plans, and Clinical Study Reports.

• Lead and manage cross-functional clinical trial team meetings, collaborating with team members on operational activities for the execution of clinical trials.

• Identify and assist in identifying investigational sites, and participate in reviewing and approving qualified sites.

• Create and review Requests for Proposals, vendor specifications, and participate in the vendor selection process.

• Negotiate contracts, budgets, and timelines with CROs, vendors, clinical sites, and other external partners.

• Review study invoices and manage monthly accruals for assigned studies.

• Coordinate and train team members and external partners (vendors, sites, etc.).

• Prepare and maintain study and program files, documentation, and other essential records.

• Provide routine updates to management on the status of ongoing studies.

• Participate in internal and external study-related audits as needed.

• Ensure compliance with internal processes and Good Clinical Practice (GCP) guidelines.

• Collect and maintain Trial Master File documentation.

• Attend Investigator Meetings and site visits as required.

Additional Skills & Qualifications:

• Education: Minimum BA/BS degree required.

• Experience: 5+ years.

• Regulatory Knowledge: Demonstrated understanding of FDA, EMA, GCP, and ICH regulations and guidelines.

• Leadership: Ability to provide effective leadership to clinical sites and CROs.

• Attention to Detail: Strong problem-solving skills and attention to detail.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.