Director, Country Operations Management

This is what you will do:

The CRA Director Country Operations Management (CRA DCOM) is responsible for day-to-day management of a dedicated functional group(s) within Country Operations, and is responsible for planning and utilization of staff resources, objective setting and performance development. The CRA DCOM is responsible for their direct reports delivery to study expectations.

It is also expected that the CRA DCOM may contribute to regional/global initiatives as delegated.

In some countries the CRA DCOM may also take other responsibilities such as Director Country Operations Management (DCOM if required, as agreed with the Head of Country Operations (HCO).

You will be responsible for:

• Leadership of dedicated functional group within Country Operations.
• Ensures adequate resources for the studies assigned, and workload of direct reports is optimized, and ensures appropriate and timely assignment to projects by liaising with relevant stakeholders (HCO, PMCO, global study team, etc).
• Development and performance management of direct reports, including implementation of development and training plans and coaching of direct reports.
• Prepares salary and bonus proposals for direct reports based on their performance in close collaboration with responsible HCO
• Manages new staff interviews, hiring, onboarding process, for full-time and and in-sourced staff
• Ensures that study activities at country level comply with local policies and code of ethics, and ensures team delivery to committed site activation and recruitment targets
• Contribute to Country feasibility analysis for new potential clinical trials (as applicable)
• Contribute to a consistent, efficient and agile organization and its functioning at country level by ensuring CRAs are performing to the highest standards with patients and site staff in mind
• Contribute to quality goals and country level quality plans including eTMF, CTMS, study conduct, CRA training, and Inspection Readiness; contributes to quality improvement of study processes and other procedures.
• Ensures inspection readiness at site and country level.
• Mitigate risks through ongoing surveillance and prompt identification of any quality concerns and support resolution as required (i.e: CAPAs). This may include conducting Site Visits triggered by observed quality signals and coordination with quality and project management partners.
• Ensure collaboration with local Medical Affairs team , Medical Advisor Pipleline, and other relevant stakeholders.
• Conduct regular accompanied/assessment visits with CRAs including regular review of monitoring reports to ensure adherence to best practices, study requirements, corporate processes, and industry and local regulations
• Conduct ongoing training and development of CRAs
• Serves as an escalation point for CRAs in managing site issues, ensuring that monitoring activities are conducted according to expectations.
• May act as a site liaison to facilitate discussion and resolution of site compliance with ICH GCP, quality concerns, and process improvements
• Collaborates with in-country local roles (PMCO) in proactive monitoring of quality and study conduct based on agreed KPIs. Maintain tools to document and track clinical monitoring activities as required.
• Review and approve travel and expense reports according to corporate policies and standards
• Ensure compliance with the study Monitoring Plans including timing and frequency of monitoring visits, data checks, and overall clinical trial site management.

If CRA DCOM takes other role in combination to current responsibilities, please refer to the corresponding Job description.

You will need to have:

• Bachelors degree, preferably in life science.
• Minimum 7 years of experience in Clinical or Development Operations (CRA / Sr. CRA / Project management) or other related fields.
• Minimum of 3 years of CRA experience monitoring interventional, Phase 2 or Phase 3 clinical trials with demonstrated proficiency in the implementation, monitoring and management of clinical study sites.
• Previous direct line management experience, preferably in a field-based setting with internal delivery of pivotal clinical trials and proven excellence in operational delivery of clinical studies concurrently across multiple projects.
• Excellent interpersonal skills, proactivity and assertiveness and ability to establish productive internal and external partnerships, including alliance partners and third party suppliers.
• Deep knowledge of country regulatory requirements and ICH/GCP guidelines.
• Manage change with a positive approach for self, team and business. Views change as an opportunity to improve performance and add value to business.
• Excellent organizational, analytical, influencing and negotiation skills.
• Excellent presentation and communication skills, verbal and written.
• Excellent knowledge of spoken and written English.
• Ability for national and international travel.
• Integrity and high ethical standards.

We would prefer for you to have:

• Advanced degree in a scientific discipline.
• Good understanding of cross-functional roles and responsibilities including IMP management, data management, and patient safety.
• Ability to work in an environment of remote collaborators.
• Excellent decision-making skills.
• Good conflict management skills and ability to handle crisis.
• Excellent team building skills also in cross-functional teams.
• Understanding of rare disease drug development
• Good intercultural awareness.
• Recent experience in Health Authority/Regulatory Inspections
• Understanding of risk-based monitoring and central monitoring practices and tools.

Date Posted
25-Apr-2025

Closing Date
08-May-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 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.