Senior Site Manager – Oncology

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

📋 Description

• Serve as the main local point of contact for designated sites involved in specific trials.

• Actively engage in site feasibility assessments and/or Site Qualification Visits (SQVs).

• Participate in investigator meetings as required.

• May assist in preparing materials for meetings and could be asked to present during investigator meetings.

• Carry out activities related to site initiation and start-up, preparation and execution of site monitoring (including remote monitoring), site management (utilizing study-specific systems and various reports/dashboards), and site/study close-out in accordance with SOPs, Work Instructions (WIs), and policies.

• Implement an analytical risk-based monitoring model at the site level and collaborate with the site to ensure prompt resolution of issues identified during monitoring visits.

• Independently handle and execute all tasks with minimal supervision.

• Ensure that site personnel are adequately trained and that their training records are complete and precise throughout all phases of the trial.

• Work closely with the Local Trial Manager (LTM) and central study team during the site activation phase to expedite the process and activate the site in the shortest time possible.

• May be called upon to assist in providing solutions to challenges encountered at other sites in the country.

• Contribute to the development of site-level recruitment strategies and contingency planning in collaboration with other functional areas.

⛳️ Requirements

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

• At least 2 years of experience in clinical trial monitoring is required.

• A minimum of 2 years of experience in Oncology is required.

• Experience with Phase II and Phase III Clinical Trials is preferred.

• Knowledge of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations, is essential.

• A strong understanding of GCPs, company SOPs, local laws and regulations, assigned protocols and associated protocol-specific procedures, including monitoring guidelines, is required.

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

• Strong written and verbal communication skills are required.

• Willingness to travel up to 60%, including overnight stays away from home, is essential.

• A valid Driver's License issued in one of the 50 United States along with a clean driving record is required.

🏝️ Benefits

• Annual performance bonus

• Consolidated retirement plan (pension)

• Savings plan (401(k))

• Vacation - 120 hours per calendar year

• Sick time - 40 hours per calendar year; for employees residing in 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