Senior Study Manager

Senior Study Manager

We are seeking a dedicated and experienced Senior Study Manager to oversee clinical studies at a global level, particularly a Pan Tumor Phase II study involving multiple indications. This dynamic and ever-changing role requires the management of complex studies with a focus on patient enrollment and site activation across various regions including Europe, Turkey, Poland, and Latin America.

Responsibilities

• Ensure delivery and execution of clinical studies in adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), FDA regulations / EU Directive, and ICH guidelines.
• Interact routinely with internal and external stakeholders to communicate project status, escalate issues, and troubleshoot routine inquiries.
• Lead development of the clinical study plan, including critical path activities and interdependencies for assigned studies.
• Create and ensure adherence to the cross-functional Clinical Study Oversight Plan.
• Provide operational input into study protocol profiles, final protocols, and amendments.
• Lead document review and coordination for the protocol and amendments, including medical writing tasks.
• Oversee CRO and vendor selection processes and manage their scope of work.
• Monitor clinical trial performance and quality metrics and ensure necessary actions are taken.
• Proactively assess potential risks to the study and propose mitigation plans.
• Oversee the management of CROs and 3rd party vendors to ensure compliance with quality measures and adherence to timelines and budget.
• Prepare and execute meetings with vendors, regional teams, and investigators.
• Support department by codifying existing knowledge, best practices, and preparing training in area of expertise.

Essential Skills

Additional Skills & Qualifications

Work Environment

This role is 100% remote, with candidates ideally located in the Eastern Timezone or local to the NJ / PA / NY area. Candidates should be open to and flexible with face-to-face meetings.

Pay and Benefits

The pay range for this position is $85.00 - $95.00 / hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following :

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on May 9, 2025.

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.

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 due to a disability, please email actALENTaccommodation@actalentservices.com for other accommodation options.