Global Study Associate Director

What you’ll do:

• Lead, provide guidance, and delegate appropriately to a cross-functional study team or supervise outsourced delivery activities to ensure the clinical study progresses as planned, driving achievement of milestones according to timelines, budget and quality standards. May hold accountability and/or oversight of several studies.

• Lead and facilitate communication across all functions, including external partners and service providers. Lead and conduct investigator meetings and other study related meetings.

• Provide input and hold accountability for the development of study level documents (i.e., Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)

• Ensure all external service providers (i.e., Contract Research Organizations (CROs), central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that oversight is documented and any issues are escalated appropriately. May participate in vendor selection activities.

• Develop and maintain relevant study plans including required input into study level quality and risk management planning (e.g., risk-based quality management, proactive risk and contingency plans, etc.) ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team

• Accountable for ensuring that information in all systems applied at a study-level (e.g. ACCORD/ABACUS, PharmaCM, etc.) are current and accurate.

• Measure study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and project timelines. Communicate any risks to timelines and/or quality to CPT and sDSM/DSM along with proposed mitigations

• Identify and report quality issues that have occurred within the study and collaborate with all functions as necessary

• Proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders (e.g. CPT, quality assurance staff, functional line management, etc.)

• Supervise Trial Master File (TMF) completion, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness

• Ensure timely compliance with company-wide governance controls (e.g., Delegation of Authority, Sunshine Act, financial system attestations, Clinical Trial Transparency)

• Responsible for study budget re-forecasting and accountable for budget management through the study lifecycle. Providing budget progress reports including any financial risks and mitigation plans (as part of the ongoing study change control process)

• Ensure studies are inspection-ready at all times, according to ICH-GCP and AZ SOP and relevant policies/guidelines; GSAD is the primary Study Management point-of-contact in the event of an audit or inspection

• Provide regular feedback on individual performance to team members and their line managers to support their professional development; may mentor less experienced colleagues

• Work on non-drug project work such as being a Study Management representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manage

• May act as Subject Matter Expert for a particular process or system

Essentials for the role:

• 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

• Project management experience on a global level

• Demonstrated solid project management skills and knowledge of relevant tools

• Strong team leadership skills with strategic and critical thinking abilities

• Able to establish and maintain effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills

• Excellent communication and interpersonal skills

• Strong organizational and problem-solving skills

• Ability to manage competing priorities

Desirable Qualifications:

• Advanced degree (ie. Masters level education or higher)

• Project management certification

• Experience in all phases of a clinical study lifecycle