Global Study Associate Director

AstraZeneca-posted 10 months ago
$136,364 - $204,546/Yr
Full-time • Senior
Gaithersburg, MD
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The Global Study Associate Director (GSAD) is a pivotal role within Study Management, BioPharmaceuticals Clinical Operations, responsible for the delivery of clinical studies. As a GSAD, you will lead a cross-functional study team, providing direction and guidance to ensure successful study delivery. You will act as the main liaison between the study team and the Clinical Program Team (CPT), from study handover through to close-out and archiving. Your accountability to the CPT includes delivering studies according to agreed timelines, budget, and quality standards by fostering effective partnerships and collaboration within the study team and with external partners.

  • Lead, guide, and delegate appropriately to a cross-functional study team or oversee outsourced delivery activities to ensure clinical study progression as planned, achieving milestones according to timelines, budget, and quality standards.
  • Facilitate communication across all functions, including external partners and service providers.
  • Lead and conduct investigator meetings and other study-related meetings.
  • 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 AZ SOPs.
  • Ensure all external service providers (i.e., Contract Research Organizations (CROs), central laboratories, IXRS, ePRO, etc.) perform to contracted goals and timelines/budget, document adequate oversight, and raise any issues appropriately.
  • Develop and maintain relevant study plans, including required input into study-level quality and risk management planning.
  • Ensure information in all systems used at a study level (e.g., ACCORD/ABACUS, PharmaCM) are current and accurate.
  • Oversee study-level performance against agreed plans, milestones, and key performance indicators (KPIs, quality and operational) 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 within the study in accordance with relevant AZ SOPs.
  • Collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant partners.
  • Oversee Trial Master File (TMF) completion in accordance with relevant AZ SOPs.
  • Ensure timely compliance with company-wide governance controls.
  • Responsible for study budget re-forecasting following initial budget estimate provided by the CPT.
  • Accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT.
  • Ensure studies are inspection-ready at all times according to ICH-GCP and AZ SOPs and relevant policies/guidelines.
  • Act as the primary Study Management point-of-contact in the event of an audit or inspection.
  • Bachelor’s degree in medical, biological sciences, or discipline associated with clinical research.
  • 5+ years of relevant clinical experience in the pharmaceutical industry, including 2 years’ project management 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 collaborators.
  • Excellent communication and interpersonal skills.
  • Strong strategic and critical thinking abilities.
  • Strong organizational and problem-solving skills.
  • Ability to manage competing priorities.
  • Advanced degree, Master’s level education or higher.
  • Project management certification.
  • Proven project management experience on a global level.
  • Experience in all phases of a clinical study lifecycle.
  • 401(k) plan
  • Paid vacation and holidays
  • Paid leaves
  • Health benefits including medical, prescription drug, dental, and vision coverage.
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