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.
Associate Director, Project Manager Country Operations
This is what you will do:
The AD Project Manager Country Operations (AD PMCO) is responsible for the successful execution of study deliverables and the quality execution of high priority and / or complex protocol procedures through adherence to good clinical practices (GCP), evolving regulatory requirements, and ensuring quality and consistency of monitoring activities.
The AD PMCO is accountable for coordinating rapid start up activities across assigned countries together with the CRO. The AD PMCO will also drive adherence to timelines and milestones of study goals as well as identifying and communicating risks to the study team.
The AD PMCO will ensure that the CRO assigned, FSP or in house CRA monitoring activities at study sites results in the effective identification and problem solving of issues.
Works with the CRO to revise study specific country plans and timelines. Accountable for ensuring study design and timelines are achievable in the local environment and meeting performance expectations Ensures that the studies assigned in the country are appropriately resourced.
The AD PMCO will also ensure that the CRO understands complex protocol processes and procedures and may support CRA protocol-specific training.
Attendance at site visits as required together with the CRO, FSP CRA or in house CRA as applicable or with Global Medical Affairs personnel for Sponsor Oversight, Inspection Readiness or Engagement Visits.
You will be responsible for:
Reporting to the Head Country Operations the AD 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)
- Negotiation of site study budgets
- Oversight of FSP and /or contingent workers on assigned study(ies)
- Review if local regulatory documentation and oversight of local regulatory activities
- Relationship Manager with the national coordinating investigator as applicable
- Timely and accurate responses to queries from the study team
- Working with Medical Affairs to coordinate site feasibility and engagement activities
- Scheduling and leading effective country calls with local study team and/ or CRO
- Resolving ICF issues in country
- Oversight of EC submissions and facilitate resolution of queries
- Proposing potential investigator sites (HCO accountable for selection)
- Conduct training of CRAs
- Review Clinical Monitoring Documentation
- Inspection readiness activities
- Relationship Manager with sites
- Provide feedback to Internal and External Stakeholders as appropriate
- Develop and maintain tracking tools
- Drives quality efforts to proactively identify and manage risks to study quality
You will need 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 Proven experience in the oversight and delivery of operational aspects of all stages 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 Manager 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:
- A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD,) is preferred.
- 8+ years of relevant experience gained with a CRO or pharmaceutical company working on multinational clinical studies; Lead CRA/Manager experience preferred
- Proven experience in managing high priority / complex studies through phases 1 – 4 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.