Collaborate with Functional Manager (FM)/Clinical Research Manager (CRM) for country protocol feasibility (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and TDM/TDL.
Implements any local criteria for site selection.
Ensure consistent conduct of Site Qualification Visits and instruct teams on appropriate follow-up of Site Qualification Visit report and country feasibility report.
Recommends suitable sites for selection to participate in trial.
Collaborates with the Program Delivery Leader (PDL), TDM/TDL, local management/Country Head and other study team member to select final site list.
Contributes input to the study management documents at a country level or initiates development of these documents for a single country trial, as per SOPs.
Leads and coordinates local trial team activities in compliance with SOPs, other procedural documents and applicable regulations.
Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
Ensures that all Adverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.
Maintains and updates trial management systems.

Requirements

A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences or related scientific field is required.
Minimum of 2 years of clinical trial management experience or a total of at least 5 years of clinical trial monitoring and/or clinical trial management experience.
Specific therapeutic area experience may be required depending on the position.
Good understanding of the drug development process including GCP and local regulatory requirements.
Willingness to travel with occasional overnight stay away from home.
Minimum of 2 years of leadership experience.
Computer skills required.
Proficient in speaking and writing the country language and English language.
Excellent written and oral communication skills.
Demonstrated potential to be influential.
Some experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs preferred.
Ability to lead initiative/small teams.
Flexible mindset and ability to work in a fast-changing environment.
Ability to work on multiple trials in parallel.
Ability to anticipate obstacles and proactively provide solutions.

Benefits

medical, dental, vision, life insurance
short- and long-term disability
business accident insurance
group legal insurance
retirement plan (pension)
savings plan (401(k))
Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
Holiday pay, including Floating Holidays - up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial managementclinical trial monitoringdrug development processGCPsite qualificationrecruitment planningrisk managementbudget forecastingtrial management systemsadverse event reporting

Soft Skills

leadershipcommunicationmentoringcoachinginfluentialflexibilityproblem-solvingteam coordinationorganizationaladaptability