Clinical Project Manager I

Responsibilities:

• Support Digital Strategy Lead in the development of digital strategy and Client 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 guidance as well as other relevant federal and international regulations, including GCP, ICH Guidelines, client 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.

Requirements:

• 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.
• 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.
• Expertise in slide creation would be a plus.
• Self-starter, ability to navigate a highly complex and matrixed organization.