Associate Clinical Project Manager

Proclinical is currently recruiting for an Associate Clinical Project Manager with a leading biotechnology company located in Sorrento Valley, CA. As the Associate Manager, you will participate in developing study-related documents such as protocols, informed consent forms, and case report forms (CRFs), etc.

Job Responsibilities:

• Under supervision, participate in study center selection, pre-study qualification, initiation, and closeout.
• Coordinate and conduct study monitoring with CRAs to ensure study compliance, data quality, proper documentation and study completion.
• Review Essential Documents (e.g., Patient Informed Consent Forms, 1572s,)
• Contribute to monitoring plans using a risk-based approach (e.g. Risk Based Monitoring). Provides monitoring and study support resources to all studies.
• Help to develop framework for consistency in monitoring oversight across clinical programs.
• Review study protocol and study plans from an operational/monitoring perspective and provide meaningful and logical insights into its feasibility and appropriateness.
• Use study monitoring metrics to monitor recruitment, site visits, data quality, patient safety, timely submission of trip visit reports, timely escalation of any monitoring quality issues, etc.
• Contribute to development of patient recruitment strategies and identify barriers to recruitment and proposes solutions.
• Foster relationships with CRO study management and monitoring counterparts during all stages of study (start up, conduct, closeout, and query resolution/data cleanup).
• Oversees monitoring and study support team for quality and compliance. Identifies issues and escalates any areas of concern, including study conduct or personnel issues. Work with the CRO Clinical Lead/Lead CRA in managing communications and training for CRO CRAs. Leads, trains and helps develop contracted CRAs.
• Ensure consistency in processes across all programs and strict adherence to SOPs, regulations and guidelines.
• Serve as the face of company at monitoring oversight visits. Cultivate site relationships through discussions with PI and site staff. Address all study related questions.
• Oversee SSVs / SIVs / SMVs and COVs across programs as needed.
• Manage vendor activities for clinical studies ensuring that vendors are adhering to timelines, budget and are delivering quality.

If you are having difficulty in applying or if you have any questions, please contact Mary Jacobs at (+1) 267-297-3376 or m.jacobs@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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