For our customer located in Basel/Switzerland we are currently looking for a: Associate Global Trial Director (m/f/d)
- Location: CH-Basel
- Branch: Pharma
- Duration: 01.06.2023 – 31.12.2023
Tasks & Responsibilities
- Talent Development
1. Builds best talent and an inspired, curious and empowered culture to foster high
performance in a matrix environment.
- Responsible for overall management of trial management associates working
on assigned clinical trial(s) including hiring, training, coaching, capability
building, performance management and career development.
- Assigns study responsibilities to assist in the planning, conduct and reporting
of clinical trials.
- Drives functional excellence in education, implementation and compliance to
best practices and shares lessons learned for trial management
2. Contributes to cross functional activities and functional initiatives, when appropriate.
Leader of the Clinical Trial Team
1. Leads and manages the global cross-functional CTT to ensure deliverables are met
within the established timelines, budget and quality/compliance standards;
accountable for representation at all internal meetings related to the clinical trial;
chairs the CTT meetings, participates and reports study progress and
issues/resolution plan at the GCT, as extended member of the GCT.
2. Drives CTT to plan and adapt innovative solutions that future-proof our clinical trials.
3. Risk Management:
- Drives the implementation, maintenance and resolution of clinical trial quality
risk management process within the CTT.
- Ensures escalation of appropriate trial risks and issues to the program level.
- Provides oversight on quality and compliance for assigned clinical trial(s) in
conjunction with relevant line functions.
4. Trial planning, execution and close-out:
- Creates and/or drives trial level timelines.
- Leads the CTT development of global clinical trial protocol(s), by translating
the approved trial concept sheet(s) into efficient, high quality, executable
clinical protocols, and trial related documents.
- Oversees trial feasibility and facilitates development of global recruitment
plan including contingencies in collaboration with Strategic Planning &
Feasibility and Trial Monitoring organizations.
- Oversees and contributes to the development of Case Report Forms (CRFs),
edit checks, CRF completion guidelines, data quality plan and trial statistical
analysis plan in collaboration with the trial data manager, trial statistician,
statistical programmer and Clinical Development Representative(s).
- Oversees activities including document submission to Health Authority and/or
Institutional Review Board/Ethics Committee, drug supply forecast and
management, and conducting investigator’s meeting/training and other trial
related training when applicable.
- Leads development of clinical outsourcing specifications and management of
interface with Contract Research Organization.
- Ensures proper handling of all study close out activities including but not
limited to site close out, final drug accountability and audit readiness of Trial
Master File documentation.
- Manages and contributes to the development of Clinical Study Reports;
reporting of clinical trial results and internal/external publications, when appropriate.
- Uses data and digital systems and solutions to enable clinical trial planning,
management and decision making, and proactive risk management.
5. Resource Management:
- Assesses trial resource needs in collaboration with Global Trial Program Head.
- Accountable for trial level life cycle budget management including forecast
and annual cost targets; manager of and accountable for clinical work
package; accountable to ensure trial budget is revised when applicable.
- Education: Bachelor degree or equivalent degree is
required, with advanced degree preferred. At least one of the degrees in life science/healthcare is preferred.
- Languages: Fluent English (oral and written)
- Experience: ≥5 years of operational and managerial
experience in planning, executing, reporting global clinical trials in a pharmaceutical company or a contract research organization.
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.