Responsible for local management of a clinical trial in a country or countries.
Act as the primary point of contact at a country level for assigned studies.
Operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities.
Coordinate and lead the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.
Actively contribute to process improvement; training and mentoring of Clinical Trial Assistants (CTA), Site Managers (SM), and Associate Local Trial Managers.
May perform the role of Trial Delivery Manager (TDM)/Trial Delivery Leader (TDL) for single country.

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.
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.
Some experience in mentoring/coaching and providing training to other LTMs, SMs, and CTAs preferred.

Benefits

medical
dental
vision
life insurance
short- and long-term disability
business accident insurance
group legal insurance
consolidated retirement plan (pension)
savings plan (401(k))
up to 120 hours of vacation per calendar year
up to 40 hours of sick time per calendar year
up to 13 days of holiday pay including floating holidays
up to 40 hours of work, personal and family time 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 monitoringGood Clinical Practice (GCP)drug development processregulatory requirementstrainingmentoringcoachingdata quality managementprotocol compliance

Soft Skills

leadershipcommunicationteam coordinationprocess improvementwritten communicationoral communicationinterpersonal skillsorganizational skillsproblem-solvingadaptability