Job Description

This is what you will do:

The Project Manager Country Operations (PMCO) is accountable within their region for the successful execution of study deliverables and the quality execution of protocol procedures through adherence to good clinical practices (GCP), evolving regulatory requirements, and ensuring quality and consistency in timely completion of monitoring activities. The PMCO is accountable for coordinating rapid start up activities across assigned countries in collaboration with the CRO.

The PMCO will also drive adherence to timelines and milestones of study goals as well as identifying, managing, and communicating risks to the study team and preparing mitigation plans. The PMCO will ensure that the CRO assigned, dedicated, FSP or in house CRA monitoring activities at study sites results in the effective identification and problem solving of issues. The PMCO will work with the CRO to revise study specific country plans and timelines. The PMCO will be accountable for ensuring study design and timelines are achievable in the local environment and meeting performance expectations. The PMCO will also ensure that studies assigned in the country are appropriately resourced.

The PMCO will also ensure that the CRO understands complex protocol processes and procedures and may support CRA protocol specific training. The PMCO will coordinate with the Site Management Lead (SML) attendance at oversight site visits (onsite or remote) based on quality signals observed in the assigned studies, together with the CRO, dedicated CRA, FSP CRA or in house CRA as applicable or with Global Medical Affairs personnel for Engagement Visits.

You will be responsible for:

\xc2\xb7 Quality and timeliness of study deliverables (site identification, feasibility, start up, recruitment, data deliverables, filing of complete study documentation) for assigned study(ies).

\xc2\xb7 Proactive reporting of study specific issues (including monitoring metrics) to the study team via the Study Lead Country Operations (SLCO).

\xc2\xb7 Quality of monitoring oversight in the country for assigned study(ies). Meeting recruitment targets for assigned study(ies).

\xc2\xb7 CDA delivery and negotiation (based on preapproved parameters and regardless of executory party).

\xc2\xb7 ICF customization at country/site level for the assigned studies. Negotiation of site study contracts and budgets for the assigned studies at country level.

\xc2\xb7 Review of local regulatory documentation and oversight of local regulatory activities. Relationship management with the national coordinating investigator as applicable and coordination of country level engagement activities.

\xc2\xb7 Scheduling and leading effective country calls with local study team and/or CRO, as applicable.

\xc2\xb7 Leading recruitment discussions at local level for the assigned trials.

\xc2\xb7 Timely and accurate responses to queries from the study team.

\xc2\xb7 Proposing potential investigator sites in collaboration with other country functions such as SML, HCO or Medical Affairs.

\xc2\xb7 Working with key stakeholders to coordinate site feasibility. Oversight of EC/CA submissions and facilitate resolution of queries. Reviewing and approving site selection visit reports (HCO accountable for selection).

\xc2\xb7 Coordination of study specific training of CRAs for assigned trials.

\xc2\xb7 Oversight of dedicated or FSP CRAs on assigned studies.

\xc2\xb7 Reviewing Clinical Monitoring Documentation (reports, metrics, etc.) for the assigned studies.

\xc2\xb7 Inspection readiness activities coordination at local level for assigned studies.

\xc2\xb7 Relationship management with sites.

\xc2\xb7 Providing feedback to Internal and External Stakeholders as appropriate according to the relevant plans (i.e.: communication plans).

\xc2\xb7 Developing and maintaining project management tracking tools (e.g: CTMS, smart sheets, etc.).Driving quality efforts to proactively identify and manage risks to study quality.

\xc2\xb7 Supporting CRAs onboarding, particularly for study specific trainings.

\xc2\xb7 For the assigned trials PMCO should assess CRA resourcing needs. HCO keeps accountability for resourcing at country level and needs to be looped in.

You will need to have:

\xc2\xb7 Bachelor\xe2\x80\x99s Degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences or drug development is required.

\xc2\xb7 Proven experience in the oversight and delivery of operational aspects of all stages of of clinical trial process.

\xc2\xb7 Solid knowledge of clinical development processes.

\xc2\xb7 Ability to lead, troubleshoot and influence for quality and delivery.

\xc2\xb7 A track record of ensuring GCP compliance and successful risk management of complex clinical studies is expected.

\xc2\xb7 Proven experience in effectively communicating with site staff including and including KOLs and thought leaders.

\xc2\xb7 Comprehensive and current regulatory knowledge, including GCP.

\xc2\xb7 Experience conducting GCP or other training is a plus.

\xc2\xb7 Demonstrates flexibility in schedule and willingness to travel (required travel may be as high as 20% during busy periods). Good organizational skills and ability to deal with competing priorities.

\xc2\xb7 Effective communication skills (written, verbal and presentation).

\xc2\xb7 Creative thinker, curious and unafraid to ask questions.

\xc2\xb7 Innovator, willing to initiate changes, introduce new ideas, and creatively problem solve.

\xc2\xb7 Proficient with MS Office Suite (Excel, Word and PowerPoint). Bachelors level degree required. The duties of this role are generally conducted in a field environment. As is typical of a fieldbased role, employees must be able, with or without an accommodation to: travel by public transportation, automobile, train, or plane; work comfortably in a clinical setting; use a computer; engage in communications via phone, video, and electronic messaging; problem solve; engage in complex and nonlinear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

\xc2\xb7 A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD)

\xc2\xb7 5+ years of relevant experience gained with a CRO or pharmaceutical company working on multinational clinical studies; Lead CRA/management experience preferred.

\xc2\xb7 Experience in all study phases and in rare medical conditions preferred.

Previous oversight and regulatory inspection experience preferred

Date Posted 18-Jul-2023

Closing Date 31-Jul-2023

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.

AstraZeneca