Global Study Associate Director

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) AstraZeneca Standard Operating Procedures (AZ SOPs) AZ policies and best practices (e.g. AZ guidelines) and in line with AZ values and behaviours.

Accountabilities

Lead provide guidance and delegate appropriately to a cross-functional study team or overseeoutsourced delivery activities to ensure the clinical study progresses as planned drivingachievement of milestones according to timelines budget and quality standards. May holdaccountability and/or oversight of several studies.

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

• Provide input into and hold accountability for the development of essential study leveldocuments (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) inaccordance with relevant AZ SOPs.

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

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

• Accountable for ensuring that information in all systems utilized at a study-level ( PharmaCM etc.) are current and accurate.

• Oversee study level performance against agreed upon plans milestones and key performanceindicators (KPIs quality and operational) by using company tracking systems and projecttimelines and communicate any risks to timelines and/or quality to CPT and sDSM/DSM alongwith proposed mitigations

• Identify and report quality issues that have occurred within the study in accordance withrelevant AZ SOP and collaborate with all functions as necessary to overcome barriers andachieve milestones; proactively communicate findings and corrective action plans (CAPAs) torelevant stakeholders (e.g. CPT quality assurance staff functional line management etc.)

• Oversee Trial Master File (TMF) completion in accordance with relevant AZ SOPs includingensuring 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 ofAuthority Sunshine Act financial system attestations Clinical Trial Transparency)

• The GSAD is responsible for study budget re-forecasting following initial budget estimateprovided by the CPT and accountable for study budget management through the study lifecycleand for providing budget progress reports to the CPT including any financial risks and mitigationplans (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 relevantpolicies/guidelines; GSAD is the primary Study Management point-of-contact in the event of anaudit or inspection

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

• Work on non-drug project work such as being a Study Management representative in processimprovements 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

The annual base pay for this position ranges from $ 137937.60 - $206906.40 USD. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and addition our positions offer a short-term incentive bonus opportunity; eligibility toparticipatein our equity-based long-term incentive program (salaried roles) to receive a retirement contribution (hourly roles) and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program 401(k) plan; paid vacation and holidays; paid leaves; and health benefits including medical prescription drug dental and vision coveragein accordance withthe terms and conditions of the applicable of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.