Country Study Manager (CSM)
Country Study Manager (CSM)
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Job Description
Are you ready to make a difference in the world of clinical trials
As a Country Study Manager (CSM) youll 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. Youll 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:
Bachelors 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 -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why on average we work a minimum of 50% of our days each month from the office. But that doesnt mean were 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 youll 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
18-set-2025Closing Date
28-set-2025Alexion 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 lackthereof sex sexualorientation age ancestry national origin ethnicity citizenship status marital statuspregnancy (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 aninteractive dialogue with Alexion regarding an accommodation please contact . Alexion participates in E-Verify.
Required Experience:
Manager
Employment Type
Full-Time
