Associate Director Country Operations Management

This is what you will do:

Definition: Position Summary

The Associate Director Country Operations Management (AD COM) reports to the Head of Country Operations. ADCOM has the accountability to support the Country strategy implementation, to act as company culture and value ambassador and to act as line manager of local functions as agreed with Head of Country Operations.

The ADCOM is accountable for all assigned operational trial deliverables across programs are completed according to timelines, operational procedures, quality standards, SOPs and guidelines, independently if the trial is directly manage by the ADCOM or by his/her direct reports.

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

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

In some countries AD COM may also take other responsibilities such as Project Manager Country Operations (PMCO) if required, as agreed with the Head of Country Operations (HCO).

You will be responsible for:

Definition: Job Duties and Responsibilities

• Leading and developing of the dedicated functional group within Country Operations Management at local level.

• Ensures adequate resources for the studies assigned, ensure that 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 plan and regular coaching of the 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 activation and recruitment targets

• Contribute to Country feasibility analysis for new potential clinical trials (as applicable, depending on the direct reports the LM will be managing). Support the Country external scientific engagement strategy and action plan.

• Contribute to efficient COM organization and its functioning at country level by working closely with responsible HCO.

• Support HCO and in-Country COM activities as agreed with HCO, such as Site Oversight Visit reports review (as applicable, depending on the direct reports the LM will be managing) and onboarding and training of new in-Country COM functions and team members

• Act as extended local leadership team member with accountability to support the Country strategy implementation, champion the company values and support HCO with the local affiliate and global DRS team cross-functional interactions required to support local COM goals.

• Contribute to the quality improvement of the study processes and other procedures through close partnership with DCQ at Country level

• Support inspection readiness activities at site and country level.

• Collaborates in identifying patient, site or country level quality deficiencies which may lead to the creation quality events/issues, and support in discussions around those as required (i.e: CAPAs). This may include to conduct Site Oversight Visits triggered by observed quality signals

For individuals managing CRAs to:

• Plan and conduct regular accompanied/assessment visits with CRAs

• Provides support to their CRAs in managing site issues, from a monitoring perspective, ensuring that monitoring activities are conducted according to expectations.

• May act as a site liaison with prime sites for Alexion to facilitate discussion and consultation around site compliance to ICH GCP and process improvements, as agreed with their line manager.

• Collaborates with in-country local roles (PMCO and DCQ) in monitoring quality oversight based on agreed KPIs. Maintain tools to document and track clinical monitoring activities as required.

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

You will need to have:

Definition: Essential/Required Qualifications

·        Bachelors degree in related discipline, preferably in life science, or equivalent qualification.

·        Minimum 8 ( 5 for LM of CRAs only) years of experience in Development Operations (CRA / Sr. CRA / Project management) or other related fields.

·        Strong leadership to drive team growth, development and support the local COM strategy implementation

·        Pro-active identification of requirements to support future needs

·        Business acumen to understand company direction and drive the understanding at team level

·        Solution oriented attitude and ability to lead through ambiguity

·        Excellent interpersonal skills, proactivity and assertiveness.

·        Manage change with a positive approach for self, team and business. Sees change as an opportunity to improve performance and add value to business.

• Collaborates with in-country local roles (PMCO and DCQ) in monitoring quality oversight based on agreed KPIs. Maintain tools to document and track clinical monitoring activities as required.

·        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:

·        Line management experience and good resource management skills

·        Prior CRA experience

·        Excellent knowledge of the Monitoring Process.

·        Good understanding of the Study Drug Handling Process and the Data Management Process. 

·        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.

·        Good intercultural awareness.

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.