Some opportunities happen only once in a lifetime – like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
Senior Manager, Project Manager Country Operations
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. This individual 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:
Reporting to the Head Country Operations the PMCO is
- Quality and timeliness of study deliverables (site identification, feasibility, start up, recruitment, data deliverables, filing of complete study documentation) for assigned study(ies).
- Proactive reporting of study-specific issues (including monitoring metrics) to the study team via the Study Lead Country Operations (SLCO).
- Quality of monitoring oversight in the country for assigned study(ies).
- Meeting recruitment targets for assigned study(ies).
- CDA delivery and negotiation (based on pre-approved parameters and regardless of executory party).
- ICF customization at country/site level for the assigned studies.
- Negotiation of site study contracts and budgets for the assigned studies at country level.
- 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.
- Scheduling and leading effective country calls with local study team and/or CRO, as applicable.
- Leading recruitment discussions at local level for the assigned trials.
- Timely and accurate responses to queries from the study team.
- Proposing potential investigator sites in collaboration with other country functions such as SML, HCO or Medical Affairs.
- Working with Medical Affairs 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).
- Coordination of study specific training of CRAs for assigned trials.
- Oversight of dedicated or FSP CRAs on assigned studies.
- Reviewing Clinical Monitoring Documentation (reports, metrics, etc) for the assigned studies and communicate monitoring deficiencies to SML as applicable.
- Inspection readiness activities coordination at local level for assigned studies.
- Relationship management with sites.
- Providing feedback to Internal and External Stakeholders as appropriate according to the relevant plans (i.e: communication plans).
- Developing and maintaining project management tracking tools (e.g.: CTMS, smartsheets, etc).
- Driving quality efforts to proactively identify and manage risks to study quality.
- Supporting CRAs onboarding, particularly for study specific trainings.
- For the assigned trials PMCO should assess CRA resourcing needs and discuss with SML for alignment at country level and with SLCO at global level. HCO keeps accountability for resourcing at country level and needs to be looped in.
You will need to have:
- Bachelor’s level degree required. Masters or Doctoral degree or equivalent in a scientific or business discipline preferred
- Proven experience in the oversight and delivery of operational aspects of all stages of of clinical trial process.
- Solid knowledge of clinical development processes.
- Ability to lead, troubleshoot and influence for quality and delivery.
- A track record of ensuring GCP compliance and successful risk management of complex clinical studies is expected.
- Proven experience in effectively communicating with site staff including and including KOLs and thought leaders.
- Comprehensive and current regulatory knowledge, including GCP.
- Experience conducting GCP or other training is a plus.
- 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.
- Effective communication skills (written, verbal and presentation).
- Creative thinker, curious and unafraid to ask questions.
- Innovator, willing to initiate changes, introduce new ideas, and creatively problem solve.
- Proficient with MS Office Suite (Excel, Word, and PowerPoint).
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
- Bachelor's Degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences or drug development is required. A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD,) is preferred.
- 5+ years of relevant experience gained with a CRO or pharmaceutical company working on multinational clinical studies; Lead CRA/management experience preferred.
- Experience in all study phases and in rare medical conditions preferred.
- Previous oversight and regulatory inspection experience preferred.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
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 accommodations@Alexion.com. Alexion participates in E-Verify.
AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you’re interested in career opportunities with AstraZeneca, click here.