Clinical Study Manager III
Posting ID: JP-002662450
This opportunity is with a company whose research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.
Study Management and Leadership
- Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including critical path activities and interdependencies for assigned clinical stud(ies) utilizing Microsoft Project or equivalent.
- Lead the creation of the cross functional Clinical Study Oversight Plan under the guidance of the study team leader and take a leadership role in ensuring study team adherence to the CSOP and manage the overall implementation and documentation of the CSOP including activities conducted by CROs and vendors.
- Provide operational input into study protocol profiles, final protocols and amendment
- Lead document review & coordination for the protocol and amendments.
- Lead the CRO and vendor selection process in collaboration with the study team and outsourcing procurement management.
- Lead the creation of the CRO scope of work in collaboration with Outsourcing Procurement Management.
CRO, 3rd Party Vendor Management and Oversight
- Responsible for the oversight, performance and management of CROs and 3rd party vendors
- Responsible for overseeing CRO study start-up activities and coordinating with functional groups to ensure that essential site documents are collected, and sites are initiated per study plan.
- Oversee and track site initiation and enrollment activities at the country and site level and develop mitigation strategies in collaboration with the CRO.
- Vendor management is not limited to the CRO and includes 3rd party vendors (e.g. translations, trial insurance, and central laboratory, etc).
- Review CRO-generated reports - monitoring visit reports, protocol deviation reports, and analysis of site metric reports.
Additional Skills & Qualifications:
- 5-6 years' relevant experience required with a BSc.
- Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). CRA experience is preferred, Clinical Project Management skills are required.
- Demonstrates high-level knowledge of design and phases of clinical studies, global regulatory issues, CRO operations, and compliance practices Interacts appropriately with high levels of internal and external stakeholders (e.g., CROs); focuses on developing and building strong relationships
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Jean Chambers
Phone: (410) 579-3072