Senior Clinical Project Manager/Medical Affairs - Remote

Job Description

Prepares and/or reviews study-related or essential study start-up documents as they relate to the assigned human subject research trials (e.g., Clinical Protocols, Informed Consent forms, Investigator Brochures, Monitoring Plan, and other relevant study plans and charters)

Serves as a Sr. Clinical Project Manager ensuring that the Study Management team meets or exceeds the timelines and deliverables assigned to the study team.

Responsible for scheduling and running study team meetings and generation of meeting minutes and other study-related documentation.

Oversees/leads study-specific study management resources.

Accountable for setting own work direction and completing work tasks assigned by leadership team.

Develops and manages group of studies for an entire business unit or large development program.

Provides critical thinking and leadership when issues arise during execution of clinical studies, including risk management and mitigation actions.

Leads or contributes to continuous improvement activities/initiatives.

Manages relationships with sites/PIs and other study related vendors, including CRO’s

Professional Skills & Key Competencies

Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. This includes analytical problem solving.

Demonstrated ability to juggle multiple tasks and to prioritize and schedule work to meet business needs.

Demonstrated organizational, planning, and project management skills, including action oriented, focused urgency, and driving for result.

Ability to be effective in complex projects with ambiguity and/or rapid change.

Orientation for detailed work product, with emphasis on accuracy and completeness.

Working knowledge of Good Clinical Practice, and all Global, National and Local Regulations.

Education Qualifications & Previous Experience

Required: Bachelor’s Degree and 3-5 years in human subject research or equivalent

Preferred: Advanced degree (MS, MBA, etc.).

Hightly preferred: Experience directly or indirectly (matrix) managing vendors, cross-functional project team members, and has medical process/program management/ownership. This includes project leadership, employee coaching, mentorship, and supervision of support and entry-level professional associates.

Preferred: Ability to apply expertise to improve effectiveness and provide clinical and technical guidance to employees on the team.

Hightly preferred: Knowledge of and experience using and interpreting basic biomedical statistical methods.

Required: Conduct literature searches/reviews, design studies per scientific methods, and complete basic statistical analyses on results.

Hightly preferred: Experience participating in and/or managing investigational drug or medical device studies, including conducting literature reviews, study design and execution, and compliance monitoring.

Required: Experience in continuous process improvement projects and project management.

Preferred: PMP certification

Hightly preferred: Prior clinical practice experience with client product categories.

Preferred: Prior experience with medical product development.

Hightly preferred: Demonstrated excellent verbal and written communication skills, including the ability to write scientific papers and present at professional conferences.

Hightly preferred: Work experience with multi-disciplinary/cross-functional teams.

Hightly preferred: Comfortable working in a position that requires flexibility within a fast paced, multi-task matrixed environment.