Associate Site Manager – Oncology

This is a fully remote position, open to applicants in Connecticut, +10 more states.

📋 Description

• Act as the main liaison between the Sponsor and designated Investigational Sites.

• Ensure readiness for inspections and adherence to clinical trial protocols, company standard operating procedures (SOPs), Good Clinical Practice (GCP), regulations, and guidelines from the initiation of the study until site closure.

• Support site selection, qualification evaluations, subject recruitment and retention strategies, site initiation, monitoring, and close-out processes.

• Collaborate with the Local Trial Manager, Clinical Trial Assistant, and Trial Delivery Leader for comprehensive site management.

• Serve as the primary local company representative for assigned sites.

• Engage in site feasibility assessments, Site Qualification Visits, and investigator meetings.

• Conduct site initiation, start-up, remote and on-site monitoring, management of the site, and close-out activities.

• Apply analytical risk-based monitoring and address issues identified during monitoring visits.

• Verify that site staff training records are complete and accurate.

• Work with the central study team to efficiently activate sites.

• Play a role in the recruitment strategy, contingency planning, and execution.

• Ensure that study supplies and clinical drug materials are sufficient, appropriately managed, stored, inventoried, documented, and disposed of when necessary.

• Guarantee timely data entry, resolution of queries, and verification of data accuracy, validity, and completeness.

• Ensure that Adverse Events, Serious Adverse Events, and Product Quality Complaints are reported and documented within required timeframes.

• Maintain complete, accurate, and timely trial data and essential documents in relevant systems.

• Document trial activities, prepare visit reports and follow-up letters, and communicate status updates and issues to stakeholders.

• Review study files for completeness and ensure that archiving standards are met.

• Collaborate with the Local Trial Manager regarding site/study progress, challenges, Corrective and Preventive Actions (CAPA), and quality concerns.

• Participate in team meetings and training sessions, providing feedback or leading meetings when necessary.

• Serve as a local expert in assigned protocols and develop a solid understanding of the therapeutic area.

• Prepare sites for close-out and conduct final close-out visits.

• Monitor site-level expenses and ensure timely payments where applicable.

• Foster working relationships with investigators, trial coordinators, site personnel, and internal stakeholders.

• Engage in Health Authority and Independent Ethics Committee/Institutional Review Board (IEC/IRB) submission and notification processes as appropriate.

• Contribute to process enhancements and training initiatives.

⛳️ Requirements

• A minimum of a Bachelor’s degree in Pharmacy, Nursing, Life Sciences, or a related scientific field.

• At least 1 year of experience in clinical trial monitoring.

• Fundamental working knowledge of GCPs, company SOPs, local laws and regulations, assigned protocols, protocol-specific procedures, and monitoring guidelines.

• Proficient computer skills in relevant software applications and associated clinical systems.

• Excellent written and verbal communication abilities.

• Willingness to travel up to 60% with overnight stays away from home.

• Valid Driver's License issued in one of the 50 United States.

• Clean driving record.

• Experience in the oncology therapeutic area is preferred.

• Experience with Phase II and Phase III clinical trials is preferred.

🏝️ Benefits

• Consolidated retirement plan (pension).

• Savings plan (401(k)).

• Long-term incentive program.

• Vacation – 120 hours per calendar year.

• Sick time – 40 hours per calendar year; 48 hours for employees residing in Colorado; 56 hours for employees residing in Washington.

• 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.

• Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year.

• Caregiver Leave – 80 hours in a 52-week rolling period.

• 10 days Volunteer Leave – 32 hours per calendar year.

• Military Spouse Time-Off – 80 hours per calendar year.

• Inclusive interview process and accommodations for applicants with disabilities.