Associate Site Manager – Oncology

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🔥 15 hours ago

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Logo of Johnson & Johnson

Johnson & Johnson

10,000+ employees

💊 Pharmaceuticals

🧬 Biotechnology

🧘 Wellness

Pharmaceuticals • Biotechnology • Wellness

<Johnson & Johnson> is a global healthcare company that researches, develops, manufactures and markets pharmaceuticals, medical devices and consumer health products. The company focuses on innovative medicines and therapies across oncology, immunology, neuroscience and cardiopulmonary areas, and develops MedTech solutions in cardiovascular, orthopaedics, surgery and vision. Johnson & Johnson also engages in health & wellness education, large-scale manufacturing, investor activities and global social-impact initiatives.

📋 Description

• 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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