Planet Pharma ยท 19 hours ago
Clinical Trial Manager
San Francisco, CA
Full-time
Hybrid
Senior Level, Lead/Staff
$60/hr - $80/hr
8+ years expPlanet Pharma is focused on research and development to create high value therapeutics for unmet medical needs. The Clinical Trial Manager will independently manage all components of complex clinical trials, leading cross-functional teams and ensuring compliance with quality standards and regulations.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Oversee and manage all aspects of a clinical trial in accordance with company SOPs, ICH/GCP regulations and study-specific manuals and procedures
Independently lead Study Management Team(s), including cross-functional team(s), CRO(s) and third-party vendors as applicable
Develop and manage effective relationships with key study stakeholders
Responsible for key study quality metrics (i.e., eligibility, primary endpoint data, etc.)
Lead the identification, evaluation and hiring of appropriate CROs and other third-party study vendors in accordance with company SOPs
Management of CROs and other third-party vendors, including setting expectations, training, managing timelines and deliverables, and issue management
Manage the clinical study budget, ensuring the project remains within scope and that out of scope activities are identified and handled appropriately
In collaboration with the Study Management Team, identify risks to study and develop risk mitigation plans, including communication with senior management when necessary
Write or contribute to preparation of clinical protocols, informed consent forms, study manuals, case report forms, and other clinical research related documents
Ensure clinical data are reviewed in accordance with study data review plans and that a final, clean dataset is provided upon database lock
Project and coordinate study supply and packaging requirements
Manage expert consultant activities for study related activities, including effective communication. Identify program/resource gaps and proposes solutions
Provide weekly enrollment and program updates to senior management
Identify and share best practices and process improvements with colleagues to ensure optimal efficiency and consistency in Clinical Operations
Lead or participate in functional initiatives and/or activities as assigned
May mentor and develop junior clinical operations staff
Qualification
Required
Bachelor's degree or equivalent is required (life science degree is preferred)
8-10+ years in the pharmaceutical industry is required, including 4 years overseeing trial management
Vendor management experience required
Must have demonstrated problem solving abilities and strong organizational skills
Excellent written and verbal communication skills are required
Strong computer skills (MS Office) are required
Excellent working knowledge of FDA & ICH GCP regulations and guidelines is required
Must be a demonstrated self-starter and team player with strong interpersonal skills
Must possess excellent cross-functional clinical project management skills
Demonstrated ability to develop and implement SOPs and Study Plans
Some travel required
Preferred
Strong experience working as a Clinical Research Associate is preferred
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase