Senior Study Manager

Job Title:

Senior Study Manager

Job Description

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

* 7+ years of experience in pharmaceutical or biotech industry.

* Robust experience in clinical trial study start-up and enrollment boosting activities.

* Experience working with and overseeing CROs.

* Global study experience, understanding of Asia-Pac and Latin America.

* Recent oncology solid tumor experience is required.

* Bachelor of Science degree or advanced degree.

* Experience in clinical operations leading phase II or III global studies.

Additional

Skills & Qualifications

* EU CTR Experience is nice to have.

* Awareness of protocol amendments.

* Experience working with a Japanese company is a plus.

* Experience working as a CRA is a plus.

* Ability to adapt quickly to a fast-paced environment.

* Strong collaborative skills.

* Excellent written and oral communication skills.

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:

* Medical, dental & vision

* Critical Illness, Accident, and Hospital

* 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available

* Life Insurance (Voluntary Life & AD&D for the employee and dependents)

* Short and long-term disability

* Health Spending Account (HSA)

* Transportation benefits

* Employee Assistance Program

* Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Final date to receive applications

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 actalentaccom for other accommodation options.