Global Trial Leader

JOB DESCCRIPTION

Overview: The Global Trial Leader Managed Access Program provides global, regional or complex local management of a Managed Access clinical trial (s) in a country or countries.

Services/deliverables include operational oversight of assigned project(s) at the country level for end to end project management including start-up, execution, close-out, analysis and reporting.

Further, services will ensure the teams operational activities are in line with country specific regulations and trial teams are delivering high quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), International Conference on Harmonization for Good Clinical Practice (ICH-GCP), and regulatory requirements.

Partners with the Clinical Program Leader (CPL), Clinical Operations Head (COH), Global Clinical Trial Assistant (GCTA MAO), and other Global Trial Leaders (GTL) to ensure overall study delivery at the country level. Coordinates with global teams and physicians to streamline patient access into closed studies.

Education and Experience Requirements:

Bachelor's degree or equivalent required, preferably in Life Sciences.

8 years of clinical research experience in the pharmaceutical industry or CRO. Other relevant experiences and skills may be considered.

Specific therapeutic area experience may be required depending on the position.

• Oncology (Neuro)
• Pulmonary hypertension
• Cardiovascular
• Infectious disease
• Immunology

Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.

Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home according to business needs.

Excellent decision-making and strong financial management skills.

Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate.

Previous line management experience is a plus, but not required.

Flexibility and ability to manage study teams in a virtual environment.