Senior Study Manager

Actalent•Cary, NC

63d•$85 - $95•Remote

About The Position

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.

Requirements

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.

Nice To Haves

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.

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.