Description
The Global Study Associate Director (GSAD) is a business-critical role within Study Management, BioPharmaceuticals Clinical Operations, whose main accountability is the delivery of clinical studies.
The GSAD is responsible for leading a cross-functional study team and for providing the team with direction and guidance to enable successful study delivery.
Responsibilities
- Lead, provide guidance and delegate appropriately to a cross-functional study team or oversee outsourced delivery activities to ensure the clinical study progresses as planned, driving achievement of milestones according to timelines, budget and quality standards.
- Lead and facilitate communication across all functions, including external partners and service providers.
- Provide input into and hold accountability for the development of essential study level documents (i.e., Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant SOPs.
- Ensure all external service providers engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented and any issues are escalated appropriately.
- Develop and maintain relevant study plans including required input into study level quality and risk management planning.
- Accountable for ensuring that information in all systems utilised at a study-level are current and accurate.
- Oversee study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational).
- Identify and report quality issues that have occurred within the study in accordance with relevant SOP and collaborate with all functions as necessary to overcome barriers and achieve milestones.
- Oversee Trial Master File (TMF) completion in accordance with relevant SOPs.
- Ensure timely compliance with company-wide governance controls.
- The GSAD is responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget management through the study lifecycle.
- Ensure studies are inspection-ready at all times, according to ICH-GCP and SOP and relevant policies/guidelines.
- Provide regular feedback on individual performance to the study team members and their line managers to support their professional development.
Qualifications
- University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
- 5 years of relevant clinical experience in the pharmaceutical industry, including 2 years’ project management experience, or equivalent combination of education, training and experience.
- Extensive knowledge of ICH-GCP, clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development.
- Demonstrated solid project management skills and knowledge of relevant tools.
- Strong, demonstrated abilities/skills in team leadership.
- Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders.
- Excellent communication and interpersonal skills.
- Strong strategic and critical thinking abilities.
- Strong organisational and problem-solving skills.
- Ability to manage competing priorities.