Clinical Project Manager, Clinical Operations
Ocelot Bio, United States
Job Description
About Us
At Ocelot Bio we are singularly focused on Medicines that Matter. Ocelot Bio recently emerged from stealth mode backed by three top tier VCs prepared to fund the company until commercialization. We are currently working to revolutionize the treatment of hepatorenal syndrome, a complication of severe liver disease. Our existing team has deep drug development expertise, and we are looking for additional team members to pursue our ambitious vision. Focus on results, accountability to self and others, and ethical behavior are foundational principles for us. We also strive to have fun, care for one another, and find joy in the journey. We are seeking like-minded, capable players wanting to have impact in the world by changing the practice of medicine and improving patients’ lives.
Core Job Responsibilities:
The Clinical Project Manager will be responsible for planning and tracking the conduct of the study in compliance with the study budget, the quality standards and timelines. Accountable for ensuring legislation, ICH-GCP guidelines, TMF, Ocelot Bio SOPs and CRO SOPs are maintained and followed on all studies. Clinical trial oversight, vendor oversight/management; stakeholder management within Ocelot, coordination with cross functional team during study conduct.
Requirements
Position Accountability/Scope:
- Responsible for the Trial Master File and ensure it is properly maintained both at a Sponsor level and at the Vendor level.
- Review and track Indemnification and Confidentiality Agreements for Clinical Operations
- Responsible for identifying BIMO gaps and implement inspection readiness activities.
- Process Study Drug and study supply requests as warranted and help oversee Study Drug and Study Supply Tracker
- Review and assist in developing study management plans and accountabilities and oversight of database and study maintenance. Ensures all project tracker up to date with recent information (finance, oversight, enrollment, site list, essential documents, site activation)
- Responsible to identify, collect and structure the available data/hurdles impacting the project and implement course corrections in timely manner. Conducts scenario analysis amp; acts on the most appropriate scenario (in discussion with the manager)
- Responsible for stakeholders’ management (internal and external) and liable to gain support for ideas, proposals and/or projects by negotiating amp; influencing relevant stakeholders.
- Understanding of the larger business context and to collaborate effectively with various cross functional teams to lead and ensure completion work/project delivery in a timely manner.
- Able to serve as primary project contact as applicable with vendors to ensure communication is maintained and reporting and tracking schedules are adhered to through study execution phase.
- Manage and co-ordinate with cross-functional project teams to support milestone achievement and to manage study issues and obstacles and ensure compliance with standard processes, policies and procedures.
- Ensure the safety reporting requirements amp; reviews for the associated projects as per SOPs amp; Process.
- Undergo and maintain training as required by the functional role and other relevant company procedures, to ensure adherence to ICH-GCP, Ocelot SOPs, processes and procedures, Work Instructions (if any), applicable regulatory requirements and study specific needs
- Provide input for the development of proposals and study documents for clinical studies and manage project budgets.
- Contribute to achieving satisfactory study audits internal and external
- Maintain quality for study related documents and all the clinical trial activities performed
- Forecasting study milestones of assigned clinical trials and accomplishing deliverables as per the planned milestones
- Ensure together with line manager appropriate delegation of study related responsibilities during absence.
Qualifications and Experience
- BA / BS degree or equivalent preferred
- Minimum 7 years of work experience in clinical research with a preference of 3 years’ experience in Trial Master File and Document Management and 3 years in Clinical Study Management, and 1 year of Quality experience.
- Previous experience of working within the pharmaceutical industry on phase 2-3, and global clinical studies preferred.
Benefits
Compensation amp; Benefits
Ocelot Bio offers competitive cash and equity-based compensation, comprehensive health benefits, work/life balance, and flexible work arrangements for employees, as well as the opportunity to work in a growing, dynamic, and collegial environment.
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