Zenas BioPharma · 13 hours ago
Sr. Clinical Project Manager
Waltham, MA
Full-time
Hybrid
Senior Level
$136K/yr - $170K/yr
7+ years expZenas is a clinical-stage global biopharmaceutical company focused on developing transformative therapies for patients with autoimmune diseases. The Sr. Clinical Project Manager will oversee the operational management of global clinical trials, ensuring alignment with project timelines and compliance with regulations.
BiopharmaHealth CarePharmaceutical
Responsibilities
Manages all operational aspects of one or more global clinical trials from start-up to close-out; proactively identifies and resolves operational issues to assure adherence to timelines, budget and milestones while ensuring compliance to applicable SOPs, guidelines, and regulations
Participates in planning and communication with cross functional teams within clinical development to ensure proper execution of clinical trials
Participates in evaluation and selection of clinical study vendors including CRO, Data Management, IRT, Central labs, Imaging, etc
Manages and provides 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
Participates in patient recruitment planning collaborates with Clinical Site Management on activities to meet study enrollment goals and timelines
Develops and maintains study timelines, enrollment dashboards and status reports for senior management and reports on issues as required
Contributes to the development of clinical documentation including but not limited to study protocols, informed consents, Study Reference Binder, 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 IXRS specification process and UAT
Contributes to and may lead the development of presentations for clinical sites, team and investigator meetings
May assist with the development of any new or updated SOPs/processes for the clinical department
Trains, mentors and may manage junior team members
May participate in departmental initiatives
Qualification
Required
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 I, 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
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
Ability to travel domestically and internationally (minimum of 25%) including travel to the office a minimum of 6 times a year if not based locally
Benefits
Annual performance bonus
Equity
Full range of benefits
Other incentive compensation plans
Company
Zenas BioPharma
Zenas BioPharma is a biopharmaceutical company that focuses on developing immune-based therapies for patients.
51-200 employees
H1B Sponsorship
Zenas BioPharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$513MKey Investors
Royalty PharmaEnavate Sciences
2025-10-08Post Ipo Equity· $120M
2025-09-02Post Ipo Debt· $75M
2024-09-13IPO
Leadership Team
Lonnie Moulder Jr
Chairman
Orlando Oliveira
Chief Commercial Officer
Recent News
2026-01-11
Company data provided by crunchbase