Senior Clinical Project Manager: Orelabrutinib

Zenas BioPharma•Waltham, MA

1d•Hybrid

About The Position

The Sr. CPM is a member of the Zenas Clinical Operations team and will function as the Global Project Lead for a Phase 3 study in Multiple Sclerosis, responsible for the day-to-day operational management of the trial and oversight of CROs and clinical vendors. The Sr. CPM participates in a cross-functional team and partners with internal and external team members/key stakeholders ensuring alignment of activities with study projects and timeline. This position reports to the Senior Director, Clinical Project Management.

Requirements

B.A. or B.S. degree, preferably in a scientific discipline
A minimum of 7 years of industry experience in the pharmaceutical industry or equivalent, plus 4+ years of trial management experience managing study teams for phase II or III studies.
Multi-country global study experience is required.
Prior experience in management of CROs
Experience with clinical study budgets
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.
Strong leadership and decision making 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.
Flexibility to work non-traditional work hours when needed, given international operations across time zones.
Ability to travel [up to 25%]

Responsibilities

Manage all operational aspects of a global clinical trial from start-up to close-out; proactively identifying and resolving operational issues to assure adherence to timelines, budget and milestones while ensuring compliance to applicable SOPs, guidelines, and regulations.
Participate in planning and communication with cross functional teams within clinical development to ensure proper execution of clinical trials.
Chair internal Study Team Meetings.
Participate in evaluation and selection of clinical study vendors including CRO, Central labs, Imaging, ePRO, etc.
Manage and provide day-to-day oversight of CROs and third-party vendors including set-up, logistics, documentation, and clinical supplies needed for clinical trial(s)
Responsible for the trial level clinical operations budget, invoices, and change orders.
Work with Clinical Business Operations team on study budget forecast and monthly accruals.
Collaborate with the Zenas Site Relationship Manager on activities to meet study enrollment goals and timelines.
Develop and maintain study timelines, enrollment dashboards and status reports for senior management.
In collaboration with Regulatory Affairs and Site Relationship Manager, respond to RFIs from Regulatory Authorities, IRBs and Ethics Committees, ensuring responses are submitted within the required timeframe.
Contribute to the development of clinical documentation including but not limited to study protocols, informed consents, study level plans and 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 assist with the development of any new or updated SOPs/processes for the clinical department.
May train, mentor and manage junior team members.
May participate in departmental initiatives