Global Study Director BioPharmaceuticals

Locations :

Barcelona, Spain (on-site)

Warsaw, Poland (on-site)

Mississauga, Canada (on-site)

The Global Study Director (GSD) is a business-critical role within Study Management, BioPharmaceuticals Clinical Operations, whose main accountability is the operational planning and delivery of high priority and complex clinical studies or multiple studies within or across program(s).

The GSD is responsible for leading and / or supporting a cross-functional study team(s) and for providing the team(s) with direction and guidance to enable successful study delivery.

The GSD may provide input to early study planning activities based on operational expertise.

The GSD is accountable to the CPT for the delivery of a study(ies) they are leading, according to agreed timelines, budget, and quality standards by ensuring an effective partnership and teamwork within the study team.

The GSD will also collaborate with other internal stakeholders cross-functionally, and / or external partners, to identify, manage and resolve issues affecting study delivery.

The GSD leads the study team(s) and / or study oversight team(s) in accordance with the study team operating model, current clinical trial regulations ( ICH GCP), AstraZeneca Standard Operating Procedures (AZ SOPs), AZ policies and standard methodologies ( AZ guidelines) and in line with AZ values and behaviours.

The GSD provides expert input, leads knowledge management strategy and study related change management, identifies improvement needs, and leads other non-drug programs and improvement projects.

The GSD may be responsible for developing the Study Management strategy for the optimal delivery of clinical studies within their oversight.

The GSD is also responsible for providing expert guidance and operational input ongoing mentoring and support to Global Study Associate Directors.

Typical Accountabilities :

Accountable from set-up through maintenance, close-out and study archiving for the operational planning, leadership and delivery of multiple studies or overseeing (either within an asset or across assets) single, complex / novel studies (such as platform, basket, etc.

to time, cost, and quality.

• Contributes expert clinical operational input into project strategy and study design / or documents ( Protocol Concept Sheet).
• May contribute to operational interactions with external entities including regulatory agencies, preferred partners / suppliers and external collaborators
• May perform Study Management department leadership tasks as delegated by the Senior Director Study Management
• 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 breakthroughs according to timelines, budget, and quality standards.

May hold accountability and / or oversight of several studies.

• Lead and facilitate communication across all functions. Collaborate with other functions to establish strategies and identify alignments aimed at increasing efficiency of global study teams.
• Lead and conduct investigator meetings and other study related meetings.
• Provide input into and hold accountability for the development of essential study documents in accordance with relevant AZ SOPs.
• Ensure all external service providers engaged at the study level are performing to contracted goals and timelines / budget.

Ensure adequate oversight is documented and any issues are raised appropriately. May participate in vendor selection activities.

• Develop and maintain relevant study plans as well as detailed and realistic study timelines.
• Accountable for ensuring that information in all systems utilized at a study-level ( ACCORD / ABACUS, PharmaCM, etc.) are current and accurate.
• Accountable for leading the identification of overall study-level risk management activities. Ensure mitigation strategies are implemented effectively and that issue escalation pathways are clear to the entire study team.
• Oversee study level performance against agreed upon plans, milestones and key performance indicators. Communicate key risks and proposed mitigations to applicable stakeholders.
• Maintain oversight over quality issue reporting in accordance with relevant AZ SOPs and collaborate with all functions and / or external service providers as necessary to implement corrective and preventative actions.
• Oversee Trial Master File (TMF) completion from study start until archiving, in accordance with relevant AZ SOPs.
• Ensure timely compliance with company-wide governance controls ( Delegation of Authority, Clinical Trial Transparency, etc.).
• Accountable for study budget management (and re-forecasting where required) through the study lifecycle. Provide budget progress reports and highlight financial risks and mitigation plans.
• Maintain oversight of study inspection-readiness, in accordance with ICH-GCP, AZ SOPs and relevant policies / guidelines.

Act as the functional lead in the event of an audit or inspection.

Oversee individual performance of study team members and ensure resource is utilized efficiently. Identify and communicate resource gaps for assigned studies.

May mentor less experienced colleagues.

• Work on non-drug project work such as process improvements as discussed and agreed upon with their line manager.
• May act as Subject Matter Expert for a particular process or system within Study Management.
• Recognize opportunities for new ways of working and share experiences across teams.

Education, Qualifications, Skills and Experience

Essential :

• University degree (or equivalent educational / work experience), preferably in medical or biological sciences or discipline associated with clinical research
• Minimum of 7 years progressive experience in clinical research, with at least 5 years of clinical development project management experience (or equivalent)
• Extensive knowledge of ICH-GCP, relevant regulatory / ethics requirements and clinical / drug development and demonstrated abilities in clinical study management processes and clinical / drug development
• Thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs
• Extensive and proven experience project management and in driving operational delivery to timelines, cost and quality
• Strong strategic and critical thinking abilities
• High adaptability and agility in planning and operationalize new ways of working and innovations
• Ability to manage complex situations. Proven complex problem solving and decision-making skills.
• Excellent attention to detail and ability to multi-task in a fast-paced and dynamic environment
• Experience and strength in leading and managing cross-functional study teams
• Strong abilities in establishing and maintaining effective working relationships with internal and external stakeholders, along with strong conflict management skills
• Proven experience leading delivery through internal and external organizations
• Experience in external provider oversight and management
• Excellent collaborative communication skills (verbal & written) in English and strong interpersonal skills
• Demonstrated abilities in mentoring and providing effective guidance and direction to study team members
• Ability to manage multiple competing priorities

Desirable :

• Advanced degree, Masters level education (or higher)
• Project management certification
• Proven project management experience on a global level
• Experience in all phases of a clinical study lifecycle

Date Posted

05-jun-2024

Closing Date

29-jun-2024