Country Study Manager

Location: Warsaw

Hybrid Model: 3 days per week from office

The Country Study Manager (CSM) has local responsibility for the delivery of the studies in compliance with Good Clinical Practice (GCP), and regulatory requirements.

The CSM works in close collaboration with Study Start-Up (SSU) manager, Clinical Study Administrator (CSA) and other CRAs in Country Operations Management (COM) to ensure that study commitments are achieved in a timely and efficient manner in the country level. The CSM may have responsibility for actively interacting with Regulatory Authorities / Ethics Committees in the Counrty and may support the submission and approval processes for assigned projects.

The CSM is responsible for ensuring that all requirements for site activation are in place for the agreed number of centers in clinical studies according to SOPs. 

The CSM will work closely with Head of Country Operations (HCO), and/or Associate Director Country Operations Manager (AD COM), to ensure adequate study resourcing. 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 will be responsible for:

• 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 global study team and country leadership team
• Quality of monitoring oversight in the 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.
• Leading recruitment discussions at local level for the assigned trials.
• Timely and accurate responses to queries from the study team.
• Conduct of site feasibility for allocated studies
• Conduct and/or oversight of EC/CA submissions and facilitate resolution of queries.
• Coordination of study specific training of CRAs for assigned trials.
• Oversight of dedicated or FSP CRAs on assigned studies, when applicable.
• Reviewing Clinical Monitoring Documentation (reports, metrics, etc) for the assigned studies.
• Inspection readiness activities coordination at local level for assigned studies.
• Driving quality efforts to proactively identify and manage risks to study quality.
• Performing selection, initiation, interim monitoring and closeout visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Clinical Monitoring Plan (CMP).
• Driving performance at the sites. Proactively identifying and ensuring timely resolution to study-related issues and escalates them as appropriate.
• Training, supporting and advising Investigators and site staff in study related matters, including Risk Based Quality Management (RBQM) principles.
• Development of recruitment plans with each site and managing and supporting enrollment to ensure sites and studies meet enrollment milestones. Document recruitment barriers and mitigation plans.
• Ensure agreed monitoring KPIs are observed and remain within the agreed quality acceptable ranges (Action Items aging, SDV metrics, Data entry metrics, query aging, MV reports metrics, etc.)
• Preparing and finalizing monitoring visit reports in CTMS and provide timely feed-back to the Principal Investigator, including follow-up letter, within required timelines and in line with Alexion SOPs.
• Ensuring timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Alexion SOPs and local requirements. Supporting/participating in regular QC checks of the eTMF
• Collaborating with local Medical Affairs, Medical Advisor Pipeline (MAP), Global Study Team and other internal stakeholders, as needed.

You will need to have:

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

• Solid knowledge of clinical development processes.
• Fluent English & Polish
• 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 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
• 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). 
• Valid driving license

We would prefer for you to have:

• 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. Sees change as an opportunity to improve performance and add value to 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.
• 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.
• 3+ years of relevant experience gained with a CRO or pharmaceutical company working on clinical studies; Lead CRA/Senior CRA. Management experience preferred.

 
Be among our employees who continue to make us an innovation-driven company that stands firmly among the world’s leaders in Rare Diseases. APPLY! 

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 [email protected]. Alexion participates in E-Verify.