Clinical Project Manager
Client is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Client is advancing two late-stage, potential franchise molecules, obexelimab and Orelabrutinib.
Position Summary:
The Clinical Project Manager is a member of the Client Clinical Operations team and is responsible for supporting the day-to-day operational management of a global Phase III clinical trials. The CPM, under the direction of the Clinical Operations Project Lead, participates in a cross-functional team to ensure alignment of activities with study projects and timeline. This position reports to the Senior Director, Clinical Project Management / Orelabrutinib.
Key Responsibilities:
- Under the direct supervision of the Clinical Operations Project Lead (COPL) supports the management of operational aspects of a Phase III global clinical trial, including site start up activities
- Participates in planning and communication with cross functional teams within clinical development to ensure proper execution of clinical trials.
- Attends internal study team meetings and CRO/vendor meetings. Prepares agendas, takes and distributes meeting minutes and follows up on outstanding issues assigned to him/her.
- May take on direct management of selected vendors under supervision of the COPL.
- Reviews assigned vendor invoices and change orders and provides feedback to the COPL.
- Contributes to the development of clinical documentation including but not limited to informed consents, study level plans, manuals and training materials.
- Participates in the development and design of CRFs and CRF Completion Guidelines, including participating in the EDC and IRT specification process and UAT.
- May participate in departmental initiatives.
- Additional duties as assigned
Qualifications:- B.A. or B.S. degree, preferably in a scientific discipline
- A minimum of 5 years of industry experience in the pharmaceutical industry or equivalent, plus 1+ years of trial management experience.
- Solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process.
- Independently motivated, detail oriented and good problem-solving ability. Ability to make independent, timely, and risk-based decisions
- Excellent written and verbal communication skills.
- Experience interacting with key functional stakeholders (clinical development, regulatory, QA, supply chain),
- Comfortable working in a demanding, fast-paced, start-up culture with evolving processes. Flexible and able to adapt to new situations as the business demands.
- Demonstrates flexibility to work non-traditional work hours when needed, given international operations across time zones.
- Willingness to be on-site a minimum of 6 times/year.
Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.
At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact accommodationrequest@advancedgroup.com.
