Senior Clinical Program Manager, Clinical Operations ...

Job DescriptionThe Opportunity: Senior Clinical Program Manager, Clinical Operations Compliance & Training This is a unique opportunity for a Clinical Operations Compliance Professional. As a Sr. Clinical Program Manager (Sr. CPM), you will be in a key role in the Clinical Operations, Compliance and Training function in Clinical Operations to support the development and continuous improvement of GCP infrastructure using knowledge and experience with clinical study management, clinical compliance, clinical quality, International Conference on Harmonization (ICH) Guidelines, Good Clinical Practices (GCP) and regulatory requirements. Support Clinical Operations with GCP guidance and best industry practices. Lead or support the development and continuous improvement of Clinical Policies/ SOPs/ WIs/ Templates/etc. in compliance with International Conference on Harmonization (ICH) Guidelines, Good Clinical Practices (GCP) and regulatory requirements. Contribute to the management of business and compliance metrics to assess and continuously improve oversight and inspection readiness throughout the clinical trial lifecycle. Support Clinical Operations Inspection Readiness activities. Contribute to Clinical Operations training programs to deliver standards, GCP, and regulatory requirements. Partner cross-functionally and with QA on remediation plans and continuous improvement of GCP systems, investigations, CAPAs, and audit responses. Communicate deliverable status/issues, and problem solve to ensure functional goals are met. Use all available tools to track, oversee, and communicate on project status to all key stakeholders. Participate in other Clinical Operations Compliance & Training activities as assigned.Required Skills, Experience and Education: RN or Bachelor's or Masters degree in biological sciences or health-related field required. 10+ years (Sr. CPM) direct Clinical Operations and/or Clinical Compliance and/or Clinical Quality Assurance experience in the pharmaceutical or biotech industryor Clinical Research-related experience. Strong working knowledge of FDA Regulations, GCP, and ICH Guidelines, current industry practices. Demonstrated experience successfully developing and authoring Clinical and cross-functional SOPs ensuring compliance with GCP and regulatory requirements. Experience with development and monitoring of oversight activities. Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment. Be solution-oriented by anticipating obstacles and difficulties, and proactively providing risk assessment and mitigation strategies to achieve project goals. Excellent written/verbal communication and interpersonal skills. High sense of priority and commitment to excellence in the successful execution of deliverables. Ability to analyze operational data, contribute with a mind on quality, timeliness and fiscal responsibility, make and drive decisions, multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team. Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus. Travel may be required (~25%).Preferred Skills: Oncology experience, early and/or late stage. Knowledge and/or familiarity with Ex-US region(s) regulations and requirements.Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@, @planet-pharma.co.uk, and @) and not a domain with an alternative extension like .net, .org or .jobs.

Created: 2026-04-15