Global Study Associate Director

hace 7 días

Barcelona, Barcelona, España Jr Spain A tiempo completo
col-wide

Job Description:

Location: BarcelonaAre you ready to follow the science and make a difference? As a Global Study Associate Director (GSAD) at AstraZeneca, you will be at the forefront of our mission to push the boundaries of science and deliver life-changing medicines.

This role is a key player within our Study Management, BioPharmaceuticals Clinical Operations team, responsible for leading a cross-functional study team and providing direction and guidance for successful study delivery.

You will be the main liaison between the study team and the Clinical Program Team (CPT), ensuring the delivery of a study according to agreed upon timelines, budget, and quality standards.

This is your chance to be part of a team that is not just about doing things differently, but doing what has never been done before.


Typical Accountabilities:

  • 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. 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 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.) 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. 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 utilized at a study-level (e.g. ACCORD/ABACUS, PharmaCM, etc.) are current and accurate.
  • Oversee study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and project timelines and 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 in accordance with relevant AZ SOP and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders (e.g. CPT, quality assurance staff, functional line management, etc.)
  • Oversee Trial Master File (TMF) completion in accordance with relevant AZ SOPs, 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 at all times
  • Ensure timely compliance with company-wide governance controls (e.g., Delegation of Authority, Sunshine Act, financial system attestations, Clinical Trial Transparency)
  • 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 and for providing budget progress reports to the CPT 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 the study 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 within Study Management

Education, Qualifications, Skills and ExperienceEssential:

  • 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, along with strong conflict management skills
  • Excellent communication and interpersonal skills
  • Strong strategic and critical thinking abilities
  • Strong organizational and problem-solving skills

Ability to manage competing prioritiesDesirable:

  • 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 lifecycleAt AstraZeneca, we are driven by our desire to understand and reveal new insights. We are free from fear of failure, free to ask the right questions, make bold decisions, and dig deep into the biology of complex disease. We take inspiration from within our BioPharmaceutical heritage, as well as beyond, exploring what we can take and apply. We are always listening and learning from people who live with the diseases our medicines treat. It enables us to better understand their needs and, ultimately, diagnose and design the right treatments to impact patients' lives.

Are you ready to join a team that follows the science unlike anywhere else? Are you ready to be part of a team that is not just about doing things differently, but doing what has never been done before? If your passion is science and you want to be part of a team that makes a bigger impact on patients' lives, then there's no better place to be.

Apply now and let's push the boundaries of science togetherAstraZeneca embraces diversity and equality of opportunity.

We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.

We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.

We follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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