Associate Director, Project Manager Country Operations

The AD Project Manager Country Operations (AD PMCO) is accountable within theircountriesfor the successful execution of studydeliverablesand the quality execution of high priority and / or complex protocol procedures through adherence to good clinical practices (GCP) evolving regulatory requirements ALXN/AZ working procedures with the agreed resources and ensuring quality and consistency in timely completion ofsite management andmonitoring activities.

The AD PMCO is accountable forleading local study teamsensuring rapidstart up activities across assignedstudies ensuring that sites are identified feasibility is conducted site qualifications performed the study is submitted to the relevant authorities for evaluation sites are set up monitored closed and final documentationarchived.The AD PMCO will also drive adherence to timelines and milestones of study goals as well asidentifyingmanagingand communicating risks to the study team and preparing mitigation plans.

The AD PMCO will ensure that monitoring activities at study sites results in the effective identification and problem solving of issues. AD PMCO will support CRAs in producing high quality of monitoring throughout the cycle life of the study. For that purposethe AD PMCO will ensure that CRAs assigned to the study understand complex protocol processes and procedures and may support CRA protocol-specific training. AD PMCO will alsoidentifyany resourcing issue and discuss with the relevant stakeholders (i.e:relevant people manager) to ensure that assigned studies are appropriately resourced.

The AD PMCO will be accountable for ensuring study design and timelines are achievable in the local environment and meeting performance expectations.

The AD PMCO in coordination with other stakeholders (e.g: Quality Representative Head of Country OperationsPeopleManager etc) and as part of the exercise ofcountry risk assessment will identify the need to conduct oversight site visits / accompanied site visits. Those might be conducted by the AD PMCO or other functionsaccordingly with the ASV guidanceand under to accountability of HCO.

The AD PMCO will remain accountable for the delivery of the recruitment at country level. The AD PMCO willliasewith localaffiliateand global functions toimplement the most effective Country and Site recruitment action plan to deliver the committed recruitmentwith quality.

You willbe responsible for:

• Quality and timeliness of study deliverables: site identification feasibility start up recruitment data deliverables filing of complete study documentation andsitesclosures for assigned study(ies). This includes:

• CDA delivery and negotiation (based on pre-approved parameters and regardless of executory party).

• Conduct of country feasibility assessment of potential studies with the highest quality in collaboration withlocal affiliate functions and other global stakeholders.

• Ensuring site selection process is conducted byidentifyingpotential sites/investigators performing initial Site Quality Risk Assessment and conducting Site Qualification Visits to evaluate suitability and quality risks.

• Ensuringtimelysubmission of application/documents to evaluating authorities (i.e: EC/IRB and Competent Authorities as applicable) at start up and for the duration of the study in line with local regulations. This will include the coordinationand collaboration with the start up positions (where available) of the preparation of the country level Master Informed Consent Form (MICF) andsubsequentsite level ICFs as including any relevant translation in line with relevant SOPs. country/site level for the assigned studies.

• Collaborationforthe negotiation of site study contracts and budgets for the assigned studies at country level in coordination with other functions such asstart upmanager. The AD PMCO will ensuretimelypreparation of local Master CSA (including site budget) and amendments as applicable in the country.

• Ensuring that all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness prior to setting sites ready toenroll and in line with applicable SOPs.

• Driving thecompliance with the committedsite activation projections for the assigned studies

• Set up and maintenance of the study in CTMSat studycountry level as well as local registries and websites as required by local laws and regulations.

• Oversight management and coordination of monitoring activities from site activation through to study closure at country and site levelin accordance withthe Monitoring Plans.

• Meeting recruitment targets for assigned study(ies) and driving theCountry/site recruitment action planto deliver therecruitment projections for the assigned studies.

• Proactive reporting of study-specific issues (including monitoring metrics) to the study team.

• Functional reporting to HCOandLMincluding:

• Updates about the performance oflocalstudy team (CRAs CSA etc.)

• Regular information at country level on study/iesand planned study milestones/keyrisks andissues.

• Leading risk-based quality meetings project performance reviewsetcfor the assigned studies.

• Regular information on any research related information including sites/investigators/competing studies that might be useful for the local market.

• Report regular updates on assigned projects progresses risks action plans

• Pro-activelyidentifypotential risks at Countrylevel andtimelyescalateand provide risk mitigationplanto HCO.

• Supporting HCO to drive the Country strategy to achieve Country goals. Proactivelyidentifyand leadactions and projects to implement at Country level aligned with Country goals and strategy defined by HCO to support the growthand performance process improvement.

• Relationship management with the nationalkey opinion leaders involved in the relationship management with key Patient Advocacy Organization and other external stakeholders which can have impact on the Country rare disease strategy in clinical development.Accountable for the Country external scientific engagement plan for the assigned study and/or therapeutic area.Supporting other Country teammemberwith the implementation of theactivities associatedtothe external scientific engagement plan.

• Potential to act asmentor of SeniorManager PMCOand Country Study Manager.

You will need to have:

• Strong leadership:including the ability to make decisions independentlyabilityto combineroleof formal informal leadermentorand coach.Independentlydeterminesthe goals for the local study team prioritize them implementthestrategic line of development of the entrusted directions.Ability to leadtroubleshootandinfluencequality and delivery.

• Strong communication skills:have strong social skills to build powerful andtrustfulrelationshipswith internal and external stakeholders.To be recognized asa reliablesource of support and guidance by theglobalstudyteammanagersand colleagues.Good independent management of tense anddifficultsituationssupporting the team to keep focus on the goalsobjectiveand company values.Proven experience in effectively communicating with site staff including KOLs and thought leaders.Effective communication skills (writtenverbaland presentation). Good intercultural awareness.

• Excellent organizational skills and planning:independently plan and manage projects of any complexity including managing the budget of projects.Ability to work effectively cross-functionally.Independentlyandtimelyrisksidentification and development of mitigation and action plan. Proven experience in oversight and leading the delivery of operational aspects of all stages of the clinical trial process. Solid knowledge of clinical development processes withpreviousproject/site management experience.A track recordof ensuring GCP compliance and successful risk management of complex clinical studies is expected. Comprehensive and current regulatory knowledge including GCP. Experience conducting GCP or other training is a plus. Good organizational skills and ability to deal with competing priorities.

• Champion of the company values.

• Flexibility in schedule and willingness to travel (travel may be as high as 20% during busy periods).

• Proficient with MS Office Suite (ExcelWordand PowerPoint).

• Excellent knowledge of spoken and written English.

Minimum Qualifications:

• Bachelors Degree or equivalent in one of the disciplines related to clinical practice/health care life sciences or drug development is.A clinical or advanced degree (RN MPH MS MA MBA PharmD) is preferred.

• Aminimumof 5 yearsof relevant experience gained with a CRO or pharmaceutical company working oninternal delivery modelmultinational clinical studies; Lead CRA/management experience preferred.

• Strong project management skills.

• Proven experience in managing high priority / complex studies through phases 1 4 and in rare medical conditions preferred.

• Previousoversight and regulatory inspection experience preferred.

• Excellent understanding of theend to endClinical Study Process including monitoring.

Why AstraZeneca

At AstraZeneca were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres no better place to make a difference to medicine patients and society. An inclusive culture that champions diversity and collaboration and always committed to lifelong learning growth and development. Were on an exciting journey to pioneer the future of healthcare.

So whats next

Are you already imagining yourself joining our team Good because we cant wait to hear from you!

The annual base pay for this position ranges from $142171.20 - 213256.80 USD Annual . 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 to participate in 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 coverage in accordance with the terms and conditions of the applicable plans. Additional details 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.