Precision Medicine Group · 6 months ago
Join our Talent Community- Clinical Trial Manager
San Francisco, California, United States
Full-time
Onsite
Senior Level
5+ years expPrecision Medicine Group is a team of clinical trial experts dedicated to the success of clients and improving patients' lives. The Clinical Trial Manager will lead and manage clinical teams, ensuring quality delivery and adherence to timelines while fostering collaboration and communication with sponsors and team members.
BiotechnologyHealth Care
Responsibilities
Management and operational delivery of the clinical elements within a trial, including site feasibility and selection, start-up, clinical plans and document development, subject enrollment, site engagement and support, monitoring planning and execution, resourcing, regulatory documentation, data cleaning activities, and close-out
Successful execution of assigned trials and ensuring completion of trial deliverables
Ensuring appropriate communication and ongoing oversight of assigned trial(s) by working in close collaboration with the sponsor and other functional team members
Participation in and presentation at sponsor meetings, including bid defenses, kick-off meetings, investigator meetings, and face-to-face meetings
Mentoring and training team members
Identifying challenges to study timelines/deliverables and offering creative action plans to the team/sponsor
Leading CRAs as they establish relationships with their sites for high quality oversight of monitoring, regulatory, IP, and overall site correspondence activities
Contribute to company and department initiatives to grow and strengthen processes, procedures, and the PFM overall
Qualification
Required
Bachelor's degree or equivalent combination of education/experience in science or health-related field
Minimum of 5 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience
Moderate independent field monitoring experience
Clinical team lead or comparable supervisory experience
Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
Experience with various EDC and eTMF systems
Excellent communication and interpersonal skills to effectively interface with others in a team setting
Excellent organizational skills, attention to detail, and a customer service demeanor
Availability for domestic and international travel, including overnight stays
Demonstrated computer skills (MS Office, M PowerPoint, etc.) and software experience (CTMS, eTMF, EDC, IXRS, RTSM, etc.)
Demonstrated ability to develop positive working relationships with internal and external organizations
Demonstrated core understanding of pertinent and various therapeutic areas, medical terminology, and clinical trial activities as it relates to the execution of a clinical development plan
Demonstrates mastery knowledge of ICH-GCP, and regulatory guidance, as well as the ability to implement
Working knowledge of clinical management techniques and tools
Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency
Results-oriented, accountable, motivated, and flexible
Excellent time management, negotiation, critical thinking, decision making, analytical, and interpersonal skills
Direct work experience in a cross-functional environment
Excellent presentation, verbal, and written communications skills
In-depth proven experience in pharmaceutical and/or device research required
Preferred
Prefer at least 2 years of CTM experience at a CRO, Pharma or Biotech company
Prefer at least 4 years of CTM experience at a CRO, Pharma or Biotech company
Company
Precision Medicine Group
We founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Mark Clein
Co-Founder & Chief Executive Officer
Matt DeZee
Chief Financial Officer
Company data provided by crunchbase