Clinical Project Manager I (Non-MD) jobs in United States
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Planet Pharma · 21 hours ago

Clinical Project Manager I (Non-MD)

Planet Pharma is an innovative company focused on empowering clinical development through digital health tools. They are seeking a Clinical Project Manager I to support digital strategy development, collaborate with medical colleagues, and manage multiple digital projects to enhance the quality of clinical trials.

BiotechnologyHealth CarePharmaceutical

Responsibilities

Support Digital Strategy Lead in the development of digital strategy and novel endpoint and provide input in the patient insight research, technologies evaluation, usability testing, vendor qualification, and validation of digital health tools for use in clinical trials
Collaborate with medical colleagues and Therapeutic Areas to implement digital strategies, aligned to asset strategy that generates high-quality evidence suitable to support decision making, label enhancement, or market access
Support analytical validation studies of digital tools, adhere to PFDD, DDTQ, CTTI guidances as well as other relevant federal and international regulations, including GCP, ICH Guidelines, Standard Operating Procedures (SOPs), and to functional quality standards. Stay abreast of new and evolving regulations, guidelines and policies related to digital health and clinical development
Work with internal and external partners, including vendors, BTS, procurement, regulatory, legal, and QA to enable the qualification of selected digital health tools
Manage multiple digital projects with people and project management skills, e.g. create project plans, trackers, monitor scope, budget, timeline, and report milestones/progress
Identify business needs and support the creation of reports, SOPs, publications

Qualification

Clinical developmentProject management toolsICHGCP requirementsLife science backgroundCommunication skillsCritical thinkingProblem-solvingDetail-orientedSelf-starter

Required

Bachelor's, preferred graduated training in life science, clinical, public health or related field with 1-3 years (BS) of relevant experience in the pharmaceutical, healthcare, consulting, or medical device industry
Solid understanding of the drug development process and ICH, GCP requirements, with experience in clinical development, data management, health outcome research, or regulatory science
Proficient in project management tools, e.g. Microsoft project, Planisware, smartsheet
Methodical, detail-oriented with the ability to organize and manage multiple projects, as well as collaborate and influence cross-functionally
Demonstrate critical thinking, value-evidence mindset, and problem-solving skills
Strong communication skills in verbal and writing with ability in
Self-starter, ability to navigate a highly complex and matrixed organization

Preferred

Expertise in slide creation would be a plus

Company

Planet Pharma

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Planet Pharma is a pharmaceuticals company.

Funding

Current Stage
Late Stage

Leadership Team

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Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
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Emma Morris
President, PPG Advisory Partners
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Company data provided by crunchbase