Country Study Manager (CSM)

Are you ready to make a difference in the world of clinical trials?

As a Country Study Manager (CSM), you'll be at the forefront of delivering studies in compliance with Good Clinical Practice (GCP) and regulatory requirements. Collaborate closely with the Study Start-Up (SSU) manager, Clinical Study Administrator (CSA), and other CRAs in Country Operations Management (COM) to ensure timely and efficient study commitments at the country level. The CSM acts as local study manager and/or monitor of the study in compliance with SOPs and with protocol requirements. The CSM may also be required to perform site monitoring activities and/or oversight depending on the study requirements. You'll have the opportunity to interact with Regulatory Authorities and Ethics Committees, supporting submission and approval processes for assigned projects. Dive into site monitoring activities and oversight, driving quality and performance at every step!

Accountabilities:
• Quality and timeliness of study deliverables for assigned studies.
• Proactive reporting of study-specific issues to global and country leadership teams.
• Quality of monitoring oversight in assigned studies.
• Meeting recruitment targets for assigned studies.
• CDA delivery and negotiation.
• ICF customization at country/site level.
• Negotiation of site study contracts and budgets.
• Review of local regulatory documentation and oversight.
• Relationship management with national coordinating investigators.
• Leading recruitment discussions at local level.
• Timely responses to queries from the study team.
• Conduct of site feasibility for allocated studies.
• Conduct and/or oversight of EC/CA submissions.
• Coordination of study-specific training for CRAs.
• Oversight of dedicated or FSP CRAs on assigned studies.
• Reviewing Clinical Monitoring Documentation for assigned studies.
• Inspection readiness activities coordination at local level.
• Driving quality efforts to manage risks to study quality.
• Performing selection, initiation, interim monitoring, and closeout visits.
• Driving performance at sites and resolving study-related issues.
• Training, supporting, and advising Investigators and site staff.
• Development of recruitment plans with each site.
• Ensuring agreed monitoring KPIs are observed.
• Preparing and finalizing monitoring visit reports in CTMS.
• Ensuring timely collection/uploading of essential documents into the eTMF.
• Collaborating with local Medical Affairs, Medical Advisor Pipeline (MAP), Global Study Team, and other stakeholders.

Essential Skills/Experience:
•    Bachelor's Degree or equivalent in clinical practice/health care, life sciences or drug development required; clinical or advanced degree preferred.
•    3+ years of relevant experience gained with a CRO or pharmaceutical company working on clinical studies; Lead CRA/Senior CRA. Management experience preferred.
•    Proven experience in the oversight and delivery of operational aspects of clinical trial processes.
•    Solid knowledge of clinical development processes.
•    Ability to lead, troubleshoot, and influence for quality and delivery.
•    Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
•    Proven experience in effectively communicating with site staff 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.
•    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, PowerPoint).
•    Valid driving license.

Desirable Skills/Experience:
•    Ability to work in an environment of remote collaborators and in a matrix reporting structure.
•    Manages change with a positive approach for self, team, and the business.
•    Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
•    Team-oriented and flexible; ability to respond quickly to shifting demands and opportunities.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions.  That’s why, on average, we work a minimum of 50% of our days each month from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world

At AstraZeneca, you'll find yourself immersed in a culture that thrives on innovation and collaboration. Our commitment to transforming complex biology into transformative medicines is unwavering. With resources that span globally, we are uniquely positioned to address unmet needs in rare diseases. Our entrepreneurial spirit fosters an environment where new ideas flourish, empowering you to make a real impact on patients' lives. Join us as we push boundaries in biomedical science!

Ready to embark on this exciting journey? Apply now to become part of our dynamic team!

Date Posted

Closing Date

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.