Serve as the primary contact point between the Sponsor and the Investigational Site.
Ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations.
Assist with site selection, site qualification assessment, subject recruitment and retention planning, site initiation, and close-out activities.
Partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and TDL (Trial Delivery Leader).
Contribute to process improvement, training, and mentoring of other Site Managers.
Actively participate in site feasibility and/or Site Qualification Visits (SQVs).
Execute activities within site initiation and start-up, preparation and conduct of site monitoring, site management, and site/study close-out according to SOPs, Work Instructions (WIs) and policies.
Document and communicate site/study progress and issues to the trial central team.

A minimum of a Bachelor’s degree in Pharmacy, Nursing, Life Sciences, or related scientific discipline is required.
A minimum of 2 years of clinical trial monitoring experience is required.
A minimum of 2 years of Oncology experience 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 required.
Strong 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.

Eligible for an annual performance bonus
Eligible for the Company’s consolidated retirement plan (pension) and savings plan (401(k))
Eligible to participate in the Company’s long-term incentive program
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

Senior Site Manager – Oncology, Southeast US

Key skills