Position Summary:
The Clinical Project Manager is a member of the Zenas Clinical Operations team and is responsible for supporting the day-to-day operational management of two global Phase III clinical trials, with specific emphasis on vendor management. The CPM, working closely with the Clinical Operations Global Project Leads (COPL), 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:
- Direct oversight of clinical vendors contracted directly by Zenas. Vendors include the central laboratory and central MRI imaging reader. Additional vendors may be included.
- Support vendor contract and budget negotiations, review budgets, and change orders
- Review assigned vendor invoices and change orders and provide feedback to the COPL.
- Review and approve vendor's Project Plans, manuals, and associated documents.
- Attends internal study team meetings and CRO/vendor meetings and follows up on outstanding issues assigned to him/her.
- Participate 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 and follows up on outstanding issues assigned to him/her.
- Additional activities may be assigned to support the management of the Phase III trials
Qualifications:
- B.A. or B.S. degree, preferably in a scientific discipline
- A minimum of 3-5 years of industry experience in the pharmaceutical industry or equivalent, plus 1+ years of vendor 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 come into the office a minimum of 2 days/week
#LI-Hybrid
The position is eligible for a competitive compensation and benefits package.
Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $120,000 to $150,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.
Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas' competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.