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Clinical Project Manager
Job Description
Responsibilities:
Clinical Study Leadership
- With minimal supervision, lead global clinical study teams from clinical protocol design to final clinical study report within assigned budget, scope and timeline requirements. Serves as the primary point of contact for operational oversight of assigned clinical studies.
- Utilizes project management tools effectively for organizing team meetings, maintaining action and decision logs, and facilitating effective decision making.
- Provides study updates to GCA management and project stakeholders as needed
- Leads development of clinical protocols by working collaboratively with clinical affairs team and key stakeholders. Ensures supporting documentation (i.e. case report forms, monitoring plans, data management plans, etc.) are aligned to protocol objectives and include operational efficiencies.
- Actively tracks study progress to ensure that enrollment targets, data quality, and study milestones are met.
- Effectively manages external vendors as needed, to complete clinical studies.
- Communicates direction and updates to clinical study team members, assign tasks as appropriate, and ensure that commitments are met.
- Ability to proactively identify study risks and works to mitigate them or create contingency plans.
- Maintain regulatory compliance, ensure accurate and timely documentation of the essential study documents within the Trial Master File (TMF).
- Ensure all study activities adhere to regulatory requirements, ethical guidelines, and company policies.
- Other duties as needed or required
- Excellent oral and written communication skills
- Strong interpersonal skills
- Demonstrated ability to work independently, as well as part of a multifunctional study team
- Ability to work on multiple concurrent studies and independently balance priorities to meet timelines
- 2-5 years of relevant experience
- Bachelor’s degree in Life Sciences or related field. Equivalent combination of education, training and work experience may be accepted in lieu of degree.
- PMP (Project Management Professional) Certification preferred
- Strong working knowledge of project management methodologies and tools (e.g., Microsoft Project).
- Understanding of relevant clinical research regulations (GCP, EUMDR, ISO)
- Experience with Microsoft Suite Applications (Word, PowerPoint, Excel, Teams)
- Knowledge relating to continence care, critical care and/or ostomy a plus
Pay Rate Range: $50-65/hr depending on experience
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.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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