Global Study Associate Director Single Sponsor dedicated

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. The GSAD is the main liaison between the study team and the Clinical Program Team (CPT) starting with study handover through to close-out and archiving. The GSAD is accountable to the CPT for the delivery of a study according to agreed upon timelines budget and quality standards by ensuring an effective partnership and teamwork within study team and/or external partners.

The GSAD leads the study team and/or study oversight team in accordance with the study team operating model current clinical trial regulations (e.g. ICH GCP) Standard Operating Procedures (SOPs) policies and best practices (e.g. guidelines) and in line with values and behaviours.

Essential Functions

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 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 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 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 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.

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 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 priorities

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