Project Manager

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi‑therapeutic global functional and CRO services through Catalyst Flex. The company's customer‑centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.

Position Responsibilities/Accountabilities

• Planning, tracking and delivery of efficient and high‑quality trial execution of all operational aspects of assigned clinical trials/programs from protocol inception through Clinical Study Report (CSR) and trial close out.
• Managing and driving the SOW consistent with the targeted timelines and budget for the assigned clinical trials/programs.
• Communicating to the sponsor with strict attention to budget and timeline estimates for deliverables and timely notification of changes to SOW and timelines.
• Timely communication to the sponsor on all aspects of the study, prioritizing patient safety issues.
• Collaborating with the trial/program team and all stakeholders to ensure completion of all project deliverables from contract signature to delivery of final clinical study report and project close out while complying with ICH GCP requirements.
• Managing study vendors, patient enrollment and liaising with investigators and study sites.
• Leading cross‑functional teams while understanding and managing client expectations.
• Working with the sponsor, subcontractors and Catalyst‑assigned project team members to manage resources (internal and external) to meet contracted project timeline and sponsor expectations.
• Proactively identifying, resolving/mitigating, and escalating risks or issues when necessary and communicating them to the project team to avoid negative impact on the overall project.
• Continuously looking for methods to improve overall collaboration, efficiency, and excellence with which the deliverables are achieved.
• Performing project status tracking and reporting, including participation in the monthly project review with the ELT.
• Accounting for overall integration and communication of the study parameters to all stakeholders/partners (sub‑contractors, strategic partners, internal partners, and sponsor representatives) to ensure execution of the work product.
• Ensuring effective project plans (e.g., Clinical Monitoring Plan, Communication Plan, Project Management Plan, Vendor Oversight Plan, Recruitment Plan) are developed, in place and optimal for the trial per SOW and company SOPs.
• Working proactively with the clinical trial team to set priorities in accordance with applicable project plan, company SOP and procedures, and ICH/GCP guidelines and regulatory requirements.
• Overseeing the Clinical Monitoring Plan to ensure a consistent approach to monitoring is maintained throughout the study.
• Collaborating with the internal safety team member or safety vendor to develop a Safety Management Plan and ensuring the internal and extended team members are trained on the plan.
• Reporting project resource needs to management (overage as well as shortage).
• Contributing to the development of site initiation presentations and, in collaboration with the CRA and sponsor, delivering them to sites for initiation purposes.
• Providing project/trial‑level input and coordinating tasks supporting deliverables such as feasibility analysis, recruitment projections, data collection status, data cleaning progress and strategy, data lock tracking and overall reporting of deliverable timelines.
• Developing and revising trial and site recruitment strategies/plans to support achieving the recruitment goal as driven by project milestones.
• Collaborating with Central Site Services (CSS) on the development of templates for investigator contract and budget, and investigator grant payments process.
• Team‑working with cross‑functional members (Data Management, Clinical Science, and Biostats) in protocol deconstruction, eCRF development, development and review of the data management plan, edit specifications, eCRF completion guidelines, diaries, questionnaires, and data screens.
• Monitoring and QCing the electronic Trial Master File (eTMF) throughout the project to ensure required trial documentation is filed per the TMF reference model.
• At study close out, overseeing and transferring a quality eTMF to the sponsor.
• Collaborating with internal team, sponsor, medical monitor, and partners to develop agenda and content of the project team meetings.
• Leading the project, site, internal and vendor meetings and ensuring meeting minutes and action items are captured, distributed to all team members, sponsor, and management.
• Reviewing and identifying study data for trends (per company process) and developing a plan to address any issues or concerns with data collection/entry.
• Participating in data review meetings as needed with DM, CS, and Biostats, internally and with the sponsor to review data for trends or issues and develop an action plan to address questions or concerns.
• Monitoring the quality of vendor deliverables, addressing issues with the appropriate team members and identifying opportunities to improve training, execution, and quality across the team.
• Overseeing any changes to the study because of protocol amendments per the SOW, ensuring study related documents (e.g., Amendment, ICFs, manuals, plans, eCRFs, eCRF completion guidelines and contracts) are updated and communicated to the internal and external team and vendors in a timely manner.
• Overseeing the CAPA process implementation as needed for assigned trials, collaborating with cross‑functional teams, Clinical Operations Management and Quality Management.
• Reviewing and providing input to corrective and preventative actions for Internal Quality Review findings for assigned studies and working with Clinical Operations Management to address findings.
• Facilitating and assisting Medical Writing in the development of the CSRs.
• Maintaining proficiency to current ICH and GCP regulations, guidelines, and white papers as they apply to areas of study.

Managerial Requirements/Responsibilities

N/A

Position Qualifications/Requirements

Education: Minimum of a BS/BA in a biomedical discipline or equivalent education/training is required.

Experience: Minimum of 5 years’ experience with clinical research methodology and product development activities (supporting regulatory filing, study design, monitoring, study coordination, data management, data analysis). Prior project management or project lead coordination experience is required. Minimum of 5 years’ experience with clinical research methodology and product development activities in Australia, New Zealand and Asia Pacific. Prior oncology project management or project lead coordination required.

Required Certifications: N/A

Required Skills

• Preferred experience in bid defense process.
• Proficient with Microsoft Office Suite.
• Excellent written and oral communication skills.
• Demonstrated proficiency in communicating with and motivating multiple partners/vendors/outsource partners.
• Strong organizational, problem‑solving, and analytical skills.
• Versatility, flexibility, and a willingness to work within constantly changing priorities.
• Proven ability to handle multiple projects and meet deadlines.
• Exceptional attention to detail.
• Demonstrated track record in leading successful teams to achieve aggressive timelines using creative problem‑solving techniques.
• Collaborative leadership style.
• Ability and willingness to travel as needed.
• Ability to work independently and as a member of various teams and committees.
• Good judgement with the ability to make timely and sound decisions.

Seniority level

• Mid‑Senior level

Employment type

• Full‑time

Job function

• Project Management and Information Technology
• Research Services