GD Trial Lead MAO-IIS
1. Leads the SMT as the single point of accountability for end-to-end project management including trial set-up,
execution, close-out, analysis and reporting.
- For projects executed in-house, the GTM will oversee and support local Trial Managers and teams in the
daily operational activities in line with country specific regulations and internal processes, if required.
- For projects outsourced to a CRO, the GTM will oversee and monitor the CRO’s performance on all
2. Is accountable for delivery of assigned trials within agreed/projected life of trial budget. Ensures accurate trial budget management, updates for scope changes and reconciliation of assigned trials for both Out of Pocket (OOP) costs and FTE costs. Responsible for overall contract management, including review & approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.
3. Tracks project progress against planned timelines. Monitors patient recruitment rate to ensure that target
enrollment will be met across the allocated regions/countries.
4. Provides regular status updates to SMT, project owners and Clinical Team members. Ensures required reports
are generated and available for real time tracking of project status.
5. In coordination with the CPL/COH, Study Responsible Scientist/Physician (SRS/SRP) and/or Clinical Leader,
the GTM provides adequate project-specific training to the GCO or CRO teams and to the site staff. Works with
GCO/CRO staff in the set-up and coordination of Investigator Meetings, if applicable.
6. Maintains project compliance within all applicable Health Authority (HA) regulations, guidelines, internal SOPs
and processes. Ensures quality oversight of assigned projects utilizing the available tools so that the project is
in a constant state of inspection-readiness. Participates in preparation for, and conduct of, HA inspections and
internal Quality Assurance (QA) audits.
7. Identifies and proactively manages issues in a timely manner.
- Communicates regularly with the CPL/COH.
- Escalates issues and manages risks related to resources, timelines and budgets.
- Build proposal for Action Plan(s) with the SMT to implement solutions on a project level.
8. Mentors and coaches other GTMs or TMs.
9. May be delegated to provide oversight or line manage or act as a Functional Manager for GTMs,TMs and/or GTM-CTAs, especially on complex or focused projects/programs within the CPL’s portfolio/program.
10. Maybe delegated to act as a back-up for the CPL, if needed.
• Bachelor’s degree or equivalent required, preferably in Life Sciences (e.g. Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
• 8 years of clinical trial experience in the pharmaceutical industry or CRO. Other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
• Clinical operations knowledge, project management and proficient communication skills are required. Computer literacy is also required.
• Effective study team leadership skills and proven ability to foster team productivity and cohesiveness. Flexibility and ability to manage global or regional study teams in a virtual environment are needed.
• Previous line management experience is a plus, but not required.
• Excellent decision-making and strong financial management skills are essential for this position.