Job Description

About the job

The Clinical Project Manager II (CPM II) is responsible for management and oversight of assigned clinical research trials (Phase I through Phase IV) to ensure client’s goals of time, cost, and quality performance are met. The CPM II is expected to perform most tasks independently but still requires support and guidance of the trial assigned Director and/or advanced Clinical Project Management (CPM) staff to ensure successful clinical trial execution and to support other functional team member’s management of daily trial operations. The CPM II is seen as being able to provide practical application of CPM principles in the essential functions of the CPM role listed below.

What You'll Do

Plan, implement, evaluate, and complete full execution of assigned clinical trials; may function as a global trial lead.

• Set goals and timelines, provide oversight and positive leadership to foster motivation within the team to accomplish goals within defined timelines and with high quality in the execution of assigned clinical trials.
• Provide oversight and coordination of the operational aspects of the functional areas on assigned projects to ensure compliance with International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines and trial procedures.
• Provide management of full scope clinical trial projects including global trials from start-up through analysis phase; provide oversight of functionally assigned teams members on clinical trials projects; able to manage multiple projects simultaneously.
• Provide coordination of a clinical trial project including organization, implementation, and management of scoped activities.
• Implement project activities according to scope of contracted work.
• Evaluate and manage project budget against project milestones and scope; work with the trial-assigned Director to take corrective measures where necessary to keep project in line with budget.
• Regularly assess project profit margins with trial-assigned Director at the project and project service levels and work with the trial-assigned Director and project team to understand deficiencies; support and mitigation strategies to positively impact project profit margins.
• Assess scope of work against client contractual agreements and works with trial-assigned Director to facilitate change of scope orders when appropriate.

Prepare or provide oversight and support to the development of trial plans and timelines; work with the trial-assigned Director or line manager to provide effective solutions to challenges that arise during the clinical trial project

• Participate in or provide oversight and guidance in the development of trial required deliverables.
• Serve as client contact at project operational level.
• Provide oversight to contracted vendors; review contracted specifications and maintains regular interactions with vendors to ensure meeting timelines and expectations. Provide oversight and management of third-party vendors’ financial spend.
• With support of assigned trial director, reviews and assesses trial’s KPI to ensure project progressing in a positive manner and actively works with team to mitigate activities that are outside the expected ranges.
• Provide oversight of appropriate project tracking using computer-assisted programs and ensure timely entry of project information by all trial team members to enable accurate reporting to clients and CTI executive management.
• Monitor ongoing resource needs to the project; keep appropriate functional department heads apprised of any identified resource needs or performance issues.
• Ensure that assigned clinical trial team receives appropriate trial training to facilitate effective implementation, conduct and execution of the protocol.
• Provide day-to-day oversight of Clinical Research Associate (CRA) tasks on assigned projects; provide oversight of the CRA’s management of sites and monitoring of the clinical trial data; review and approve site trip reports and escalate site issues as needed to trial assigned Director, CTI executive management and/or client/sponsor in accordance with the trial’s Project and Communication Plan.
• Attend site visits on an as-needed basis to provide support to the trial, CTI staff and/or site staff.
• Lead client and team meetings to enable effective information sharing, discussion, and decision-making; ensure accurate and complete documentation of the meeting discussions, decisions and outcomes.
• Prepare or provide oversight/approval of project status reports for assigned projects.
• Participate and provide oversight in the planning of Investigator meetings; develop meeting agendas or related materials and conduct presentations.
• Ensure completeness of the TMF through management and maintenance of the TMF for assigned studies ensuring that all trial assigned staff regularly submit documents and complete regular audits of the TMF to ensure accuracy and completeness as defined in the trial’s TMF Plan.
• Participate in business development activities as requested (RFP development, bid defense presentations, client meetings etc.).
• Suggest and participate in process improvement activities and initiatives.
• As required per region, review site and vendor invoices, approve subject milestones payments per scope; assist in the preparation of payment projections, and in the maintenance of payment records per regional needs. Support or conduct site budget negotiation for sites in their region as needed.

Regionally-Specific Essential Functions

• MEA
  • Provide expertise and support for country specific regulations and submissions as needed.
  • Conduct regional feasibility activities as needed in the identification of regions and sites for trial and RWE work.
  • Conduct RWE activities as needed in the region.

What You Bring

• Bachelor’s degree in allied health fields such as nursing, pharmacy, health or natural sciences, preferably with clinical trial management experience or an equivalent combination of education and relevant work experience
• At least 5 years clinical research experience (CRO CRA or Clinical Research Manager, Site Coordinator or Research Manager, Clinical Research Laboratory Manager) or possesses transferrable skills and experience in project management in a clinical setting or relatable industry.

Important Note
In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an@ctifacts.comemail address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.

Please Note

• We will never communicate with you via Microsoft Teams or text message.
• We will never ask for your bank account information at any point during the recruitment process.