Job Description

The Senior Clinical Project Manager will be responsible for successful management of clinical trial activities to ensure compliance with the clinical development plans, budgets, and timelines, as well as all applicable regulations, guidelines, quality industry standards, and internal standard operating procedures (SOPs) and policies. The Senior Clinical Project Manager will provide project and clinical study management expertise and leadership in areas of planning, organizing, documenting, tracking and managing day-to-day clinical trial activities.

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Key responsibilities:

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• Lead, create, facilitate, coordinate, and drive timelines for clinical trial start-up, conduct, close-out, and related day-to-day activities to ensure the project is completed successfully on time and in compliance with organizational goals and timelines, applicable regulations, International Council for Harmonisation (ICH) Guidelines, Good Clinical Practice (GCP), and SOPs/policies.
• Serve as Sponsor point of contact for external contract research organizations (CROs), vendors, and sites.
• Manage, facilitate, and/or monitor the preparation/review/completion of interdisciplinary project tasks including regulatory submissions, trial master file (TMF), clinical monitoring, site audits, site management, case report form (CRF)/clinical database, data collection/review, pharmacovigilance, medical monitoring, statistical analysis, medical writing, and vendors selection/set-up.
• Liaise with internal functional teams during the course of the project to ensure project tasks are completed in compliance with the organizational goals, quality standards, approved timelines, and within budget.
• Support the preparation, review, and updating of documents related to clinical development such as clinical trial protocols, informed consent forms, Investigator’s Brochure, laboratory manual, pharmacy manual, etc.
• Provide oversight and management of clinical vendors. Ensure the overall satisfactory performance of vendors based on the established key performance indicators (KPIs) and escalate unsatisfactory performance to the Senior Director Clinical Operations and quality representative.
• Collaborate with the CROs to create, review, and maintain effective project plans ensuring that the milestones, deliverables and timelines are met and within budget.
• Lead the request for proposal (RFP) vendor selection process.
• Review, manage, and report on study budget, completion of tasks (actual vs projected) and timelines.
• Lead, manage, and participate in the planning and conduct of investigator’s meeting.
• Ensure TMF is set up, maintained during the course of the study, and complete at the end of the study.
• Identify, evaluate, and mitigate clinical risks from project start until the end of the study. Prepare and maintain the risk management plan.
• Offer mentorship and support to Clinical Project Manager(s) and Clinical Project Coordinator(s) on project management and clinical study management challenges.
• May conduct remote and on-site monitoring visits (site qualification visit, site initiation visit, interim monitoring visit, and site close-out visits).
• May contribute to any clinical and regulatory operations project activities as deemed necessary to ensure the clinical program success.

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Qualifications:

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• Minimum of bachelor’s degree in health sciences or related degree within life sciences or equivalent experience
• Minimum of 5 years’ experience in a pharmaceutical or biotechnology company, or a contract research organization (CRO), including experience as clinical project manager managing phase 1 to phase 4 multicenter clinical trials.
• Previous clinical monitoring experience conducting on-site and remote monitoring visits.
• A self-starter and comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.
• Flexible, independent and self-motivated.
• Strong strategic, analytical and critical thinking skills.
• Ability to build relationships and establish credibility appropriately.
• Ability to prioritize, organize, plan, and successfully execute and lead multiple tasks and priorities simultaneously.
• An unwavering commitment to the highest quality of work, research ethics and willingness to learn.

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Contact:

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Please send your CV and cover letter outlining your motivation and relevant experience for the role to careers@35pharma.com quoting “35Pharma ‍” in the subject line – we are looking forward to hearing from you!