Associate Site Manager – Oncology
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Job Description
Associate Site Manager working in Oncology clinical trials across the Southeastern U.S. Ensuring compliance and managing investigational sites for successful trial execution.
Responsibilities:
- Act as primary local company contact for assigned sites for specific trials.
- Actively participate in site feasibility and/or Site Qualification Visits (SQVs).
- Attend/participate in investigator meetings as needed.
- Execute activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies.
- Implementation of analytical risk-based monitoring model at the site level and work with the site to ensure timely resolution of issues found during monitoring visits.
- Ensure site staff are trained, and the corresponding training records are complete and accurate at any point during all trial phases.
- Collaborate closely with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in shortest possible timeframe.
- Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.
- Ensure site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct.
- Ensure that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
Requirements:
- A minimum of 1 year of clinical trial monitoring experience is required.
- A minimum of a Bachelor’s degree in Pharmacy, Nursing, Life Sciences, or related scientific Discipline is required.
- Experience in the Oncology therapeutic area is preferred.
- Experience with Phase II and Phase III Clinical Trials is preferred.
- Basic working knowledge of GCPs, company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures, including monitoring guidelines, is required.
- Strong computer skills in appropriate software applications and related clinical systems required.
- Must have strong written and oral communication skills.
- Willingness to travel up to 60% with overnight stay away from home is required.
- A valid Driver's License issued in one of the 50 United States and a good driving record is required.
Benefits:
- Vacation - 120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Washington - 56 hours per calendar year
- Holiday pay, including Floating Holidays - 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
- Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member
- Caregiver Leave - 10 days
- Volunteer Leave - 4 days
- Military Spouse Time-Off - 80 hours
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