Manager, Centralized Start Up
Crinetics Pharmaceuticals
2 hours ago
Remote friendly (United States)
United States
Clinical Research and Development
Position: Manager, Centralized Start-up
Responsibilities:
- Lead country and site-level review, negotiation, and acceptance of new/updated informed consent (ICF) documentation to ensure compliance with ICH GCP, internal processes, and local regulations.
- Support cross-functional generation of study-specific master informed consent documentation.
- Optimize ICF documentation and review capabilities to align with study timelines and milestones.
- Support and/or coordinate end-to-end study start-up: feasibility, site identification, IRB/IEC submissions, essential document collection, and site activation for insourced countries.
- Collaborate with CROs, Clinical Trial Operations, Legal, Clinical Research, and other functions to ensure compliant ICFs, effective tracking of start-up activities, and timely site activation.
- Partner with Clinical Trial Operations and Clinical Monitoring to develop start-up packages and Investigator Site File templates.
- Identify, manage, and mitigate risks related to ICF review/approval and overall study start-up (with leadership support).
- Maintain, report, and act on study start-up KPIs/metrics, including informed consent form review and completion status.
- Create, maintain, and/or review start-up or site activation plans for assigned studies.
- Develop or support development of informed consent and study start-up processes, procedures, tools, and job aids.
- Support inspection readiness as informed consent process/documentation and study start-up subject matter expert.
Required Qualifications:
- BS in biological sciences (or related) and at least 7 years’ experience in the biotechnology/pharmaceutical industry.
- Knowledge of informed consent documentation and process requirements.
- Direct experience reviewing, negotiating, and finalizing informed consent documentation at site/country level.
- Direct experience in study start-up (feasibility, essential document templates/completed packages, IRB/IEC submissions and approvals).
- Critical thinking, root cause analysis, and problem-solving skills.
- Strong knowledge of Good Clinical Practices (GCP) and regulatory requirements.
- Excellent writing skills for compliant clinical trial documents.
- Strong interpersonal, oral/written communication, and presentation skills; ability to collaborate cross-functionally.
- Excellent negotiation skills and tactful approach.
- Demonstrated leadership and management skills.
- Ability to judge risks and analyze options/outcomes.
- Up-to-date knowledge of clinical trial industry trends.
Preferred Qualifications:
- Supervisory experience (2+ years).
- Experience in the Endocrine therapeutic area.
- Prior regulatory inspection experience.
Benefits:
- Discretionary annual target bonus, stock options, ESPP, and 401k match.
- Health insurance (medical, dental, vision, basic life), 20 days PTO, 10 paid holidays, and winter company shutdown.
Travel:
- Up to 10%.
Responsibilities:
- Lead country and site-level review, negotiation, and acceptance of new/updated informed consent (ICF) documentation to ensure compliance with ICH GCP, internal processes, and local regulations.
- Support cross-functional generation of study-specific master informed consent documentation.
- Optimize ICF documentation and review capabilities to align with study timelines and milestones.
- Support and/or coordinate end-to-end study start-up: feasibility, site identification, IRB/IEC submissions, essential document collection, and site activation for insourced countries.
- Collaborate with CROs, Clinical Trial Operations, Legal, Clinical Research, and other functions to ensure compliant ICFs, effective tracking of start-up activities, and timely site activation.
- Partner with Clinical Trial Operations and Clinical Monitoring to develop start-up packages and Investigator Site File templates.
- Identify, manage, and mitigate risks related to ICF review/approval and overall study start-up (with leadership support).
- Maintain, report, and act on study start-up KPIs/metrics, including informed consent form review and completion status.
- Create, maintain, and/or review start-up or site activation plans for assigned studies.
- Develop or support development of informed consent and study start-up processes, procedures, tools, and job aids.
- Support inspection readiness as informed consent process/documentation and study start-up subject matter expert.
Required Qualifications:
- BS in biological sciences (or related) and at least 7 years’ experience in the biotechnology/pharmaceutical industry.
- Knowledge of informed consent documentation and process requirements.
- Direct experience reviewing, negotiating, and finalizing informed consent documentation at site/country level.
- Direct experience in study start-up (feasibility, essential document templates/completed packages, IRB/IEC submissions and approvals).
- Critical thinking, root cause analysis, and problem-solving skills.
- Strong knowledge of Good Clinical Practices (GCP) and regulatory requirements.
- Excellent writing skills for compliant clinical trial documents.
- Strong interpersonal, oral/written communication, and presentation skills; ability to collaborate cross-functionally.
- Excellent negotiation skills and tactful approach.
- Demonstrated leadership and management skills.
- Ability to judge risks and analyze options/outcomes.
- Up-to-date knowledge of clinical trial industry trends.
Preferred Qualifications:
- Supervisory experience (2+ years).
- Experience in the Endocrine therapeutic area.
- Prior regulatory inspection experience.
Benefits:
- Discretionary annual target bonus, stock options, ESPP, and 401k match.
- Health insurance (medical, dental, vision, basic life), 20 days PTO, 10 paid holidays, and winter company shutdown.
Travel:
- Up to 10%.