Regional Clinical Operations Manager - Central Eastern Europe
Due to expansion, Clintec are currently recruiting for a Regional Clinical Operations Manager to support our growing team in the CEE Region. This is a permanent home based role, anywhere in the CEE region, however Poland and Hungary are the preferred locations.
The Regional Clinical Operations Manager will be responsible and accountable for the direct oversight of ClinTec Functional Service Provider (FSP) performance across the region. The RCOM will be the main point of contact for assigned Clinical Operations Managers (COMs) / “Partner Line Managers” (PLMs) in the region as the direct reporting line and will provide supervision, support, guidance, mentoring, coaching and counselling to those team members on a day to day basis.
The Regional Clinical Operations Manager will also be a Regional Management point of contact for ClinTec’s FSP Client(s) within the region and will be required to maintain oversight of and account for the businesses performance against client specific KPI’s and Service Level Agreements (SLA’s) across the region.
Client Relationship Management
Supports Clintec’s Global Client Relationship Management strategy and provides timely updates and responses to the client management team (e.g. Clinical Research Director or Clinical Research Manager) on regional performance and issues.
Adheres to the Global Client Communication Strategy and Lines of Communication, as agreed with the client
Participates in regular monthly regional review meetings with client representatives to report on regional developments and performance.
Represents Clintec at regional client meetings, where required.
Manages effective action, escalation and resolution of client or HQ escalated issues.
Monitors client feedback on Clinical Operations Manager(s) performance and addresses accordingly through risk mitigation, performance management and continuous improvement measures.
Individual Line Management
Conducts employee monthly one to ones, end of probation reviews and annual appraisals aligned to the global Performance Management SOP; sets, develops and reviews objectives accordingly with Clinical Operations Managers on a monthly basis.
Oversees regional performance through daily review of regional performance metrics and follow up on due or outstanding items with Clinical Operations Manager(s).
Maintains regular contact with direct reports to understand the team(s) workload, activity and performance against requirements and objectives.
Monitors and follows up to ensure Clinical Operational Manager(s) key accountabilities are being met e.g. onboarding plans are in place for all employees, regular QC visits are planned, adequate QC plans are in place and appropriate actions are planned against all identified issues.
Inspects and reviews deliverable items to ensure quality is maintained (e.g. accompanied visit schedules, accompanied visit reports, MVR QC reports, new starter checklists) to assess quality, completeness and consistency and provide guidance and feedback in line with the Quality Oversight plan.
Ensures employee performance issues are addressed appropriately by and for Clinical Operations Manager(s) e.g. correctly investigated and documented, performance improvement plans are implemented as needed appropriate follow up actions is planned and taken in a timely manner.
Oversees and reviews the completion of ongoing Clintec and client required training for direct and indirect reports to assure compliance to role required training matrices.
In partnership with Clinical Operations Manager(s) develops their individual employee training plans, objectives and succession plans aligned to career aspirations.
Manages all leave administration processes and travel approvals in line with applicable policies.
Participates in regular resource planning meetings to ensure adequate resourcing and utilisation of Clinical Operations Manager(s)
Supports Clinical Operations Managers offboarding activities to assure completion of tasks and handover of equipments on completion of assignment or exit from company.
Resourcing and Onboarding
Acts as a key driver for the company resourcing and talent acquisition strategy by ensuring Clinical Operations Manager(s) remain active in networking and talent sourcing.
Assesses and assures ability of Clinical Operations Manager(s) to independently conduct informative and discerning clinical selection interviews on behalf of the company.
Oversees the quality of candidate selection and presentation, identifying and actioning areas for improvement.
Owns the onboarding process for new Clinical Operations Manager(s) including practical and client specific induction, distribution of company equipment and stewardship of training within both Clintec and client process and procedures
Assures timely dissemination of key Clintec and client business messages to team members.
Organises and chairs regular team building sessions, group meetings, trainings, best practice sharing and other events as necessary to promote a positive working culture and consistent quality of delivery.
Previous experience as a Line Manager, ideally of regionally based staff
Management experience within Functional Service Provider business relationship.
High level of commercial awareness and ability to recognise ‘bigger picture’.
Fluency in English as well as local language
Bachelors Degree in Life Sciences, Medicine or Nursing or equivalent qualification / experience.
Knowledgeable about the drug development process, ICH-GCP and Local Regulatory Processes
Expert in clinical trial monitoring with recent practical hands on experience and the proven ability to coach, mentor and motivate others in this discipline.
Excellent communication skills including the ability to interact with clients and team members at all levels.
Good presentation skills in keeping with Clintec corporate image.
Ability to proactively identify issues and risks, and put in place mitigation and improvement measures where needed.
Empathetic individual with the ability to listen sensitively to employee or client issues and offer unprejudiced counsel, guidance and support where necessary.
Basic understanding of employment legislation or general people management.
Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.
Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package.