Company: Premier Research
Location: Sofia, Bulgaria or Kiev, Ukraine
Closing Date: 02 Jan 17
Type: Full Time
Salary (£): Competitive
Premier Research helps highly innovative biopharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and paediatric research. We’re looking for a talented and energetic Clinical Team Leader to join our team! This is an exciting opportunity to join our team in Kiev, Ukraine or Sofia, Bulgaria.
The Clinical Monitoring Team Leader is a position which combines line management responsibilities as well as monitoring and/or start up work according to country specific needs. The percentage of allocation to specific roles will be determined by the department manager, and this will depend on department needs, priorities and seniority.
The Clinical Monitoring Team Leader will line manage CRAs and/or coach and supervise Site Start-Up Managers (SUM) / Site Start-Up Associates (SSUA), based on country location and requirement. The Clinical Monitoring Team Leader will support the department manager in the maintenance of correct resourcing, initiation and execution of training initiatives, oversight of high quality standards and the continuous improvement of this department.
In this role you will be accountable for:
Assigned monitoring and start-up activities
On-boarding, training and evaluation of employees
Driving team quality standards, following industry and corporate defined standards
Driving continuous improvement in team delivery/metrics
Taking initiative to develop the team based upon audit or as other factors dictate
Regular responsibilities will include:
Performing monitoring activities as assigned
Supporting Department Management in resource planning and allocation as well as hiring and management of monitoring staff
Supporting Department Management in achieving the defined metric driver utilization and in the delivery of department profitability goals
Implementation of company policies and procedures as well as the maintenance of quality standards, especially in monitoring activities and filing of trial documents by direct reports
Maintaining up-to-date knowledge of local laws relevant to drug/device research, IRB/ethics committees’ requirements and regulatory authority regulation
Overall successful management of CRAs and trainees
Providing leadership and advice to CRAs and trainees on company procedures, SOPs, ICH-GCP, ISO14155 guidelines and local regulatory authority regulations, as applicable
Providing and/or coordinating training and mentoring of CRAs and traineeson new policies and procedures
Assessing CRA performance and perform annual appraisals, monitor career development and perform end of probationary period reviews
Performing accompanied visits with the CRA team according to the Accompanied Visit Plan agreed upon to ensure quality monitoring. Ensuring follow up actions are resolved so that Premier Research quality monitoring standards are maintained.
Coordinating audit response follow-up with the QA department for office and/or site audits
Performing the financial follow-up for local projects
Providing data as required for clinical operations performance metrics and project status metrics
Ensuring quality standards are maintained by the team
Conductong co-monitoring activities with the team as required
On-boarding, training and evaluating new employees for company success
Education and Experience:
Undergraduate degree or its international equivalent in a clinical, science or health related field from an accredited institution or a licensed healthcare professional
Demonstrated relevant clinical industry experience
Clinical trial support or pharmaceutical industry experience required
Demonstrated management, leadership, negotiation and mentoring skills
Working knowledge of computerized information systems required
Ability to read, write, and speak fluent English and fluent in host country language, if applicable
Expertise and know-how
Thorough knowledge of company procedures, SOPs, ICH-GCP/ISO14155 guidelines and local regulatory authority regulations
Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
Knowledge of web based communication tools for conferences
Willingness to travel as required
Valid driver’s license
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