Crinetics Pharmaceuticals
Discovering drugs for endocrine diseases and endocrine-related tumors. #acromegaly #crinetics #CarcinoidSyndrome
Manager, Centralized Start Up
Location
California
Posted
4 days ago
Salary
$133K - $166K / year
Bachelor Degree7 yrs expEnglish
Job Description
• Support centralized study and site activation activities
• Lead review, negotiation, and acceptance of informed consent documentation for clinical studies
• Support and coordinate study start-up activities such as feasibility, site identification, essential document collection
• Collaborate with various departments to ensure compliant documentation and tracking of study activities
• Maintain, report and action study start-up KPIs and metrics
• Create, maintain, and review any start-up or site activation plans as needed
• Support inspection readiness as informed consent process/documentation subject matter expert
Job Requirements
- BS in biological sciences or related discipline
- At least 7 years of experience working in the biotechnology/pharmaceutical industry
- Knowledge of informed consent documentation and process requirements
- Direct experience reviewing, negotiating and finalizing informed consent documentation at a site and country level
- Direct experience working in study start-up activities such as feasibility, essential document templates and completed packages, and IRB/IEC submissions and approvals
- Strong knowledge and demonstrated application of Good Clinical Practices and regulatory requirements
- Excellent writing skills for the preparation of compliant clinical trial documents
- Excellent interpersonal skills with strong oral/written communication and presentation skills
- Excellent negotiation skills
- Demonstrated leadership and management skills
Benefits
- Health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
- 20 days of PTO
- 10 paid holidays
- Discretionary annual target bonus
- Stock options
- ESPP
- 401k match
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