Manager/Sr Manager, Clinical Management
- Experience Level
Premier Research helps highly innovative bio-pharmaceutical 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, Dermatology, Oncology, and Pediatric research.
We’re looking for a talented and energetic Manager or Senior Manager of Clinical Management to join our team!
Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority. Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
As the Manager of Clinical Management, you’ll have the opportunity to lead and mentor Clinical Management staff including skills assessment, training, resourcing, performance evaluation and career development. You’ll be in close collaboration with Project Management for the successful integration of individual responsibilities within the Clinical Operations portion of the project team to ensure project execution and milestones are met. You’ll also lead in the implementation of operational management activities and participate in the development and revision of Clinical Management and Clinical Operations policy.
What you’ll be doing:
- Lead and supervise Clinical Lead staff, including performance and delivery, career development, and guidance on corporate policy, training and support; provide direction to the Clinical Leads on operational delivery for all clinical projects.
- Perform resource planning including interviewing, hiring, and management of clinical managers
- Liaise with Project Management, Clinical Monitoring Services, Biometrics and other departments to ensure proper and timely communication regarding project specific procedures and commitments
- May serve as liaison with specific Sponsors on large programs
- Ensure proper utilization and resourcing of all Clinical Management direct reports including interfacing with Project Management and Resourcing regarding assignments and workload
- Collect and analyze relevant clinical management metrics to ensure profitability and efficient process development
- Help to create and maintain clinical management process documents including SOPs and associated documents for clinical operations; develop and deliver New Hire Orientation for Clinical Operations
- Provide support for both internal and external audits
- Ongoing facilitation and assessment of Clinical Lead Mentoring Program
- Support Business Development activities as required
You’ll need this to be considered:
- Undergraduate degree (international equivalent) in clinical, science or health related field along with 5 years clinical research experience and up to 3 years line management experience.
- Knowledge of ICH / GCP regulations plus working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
- Experience with audits and audit preparation (both internal and external)
- Proven experience with Business Development activities including RFP devolvement and bid defense preparation and participation
- Knowledge of development and training programs
- Is customer service focused in approach to work, both internally and externally with strong verbal and written communication skills; approaches challenges creatively
- Highly confident and effective presenter with knowledge of web-based communication tools; excellent verbal and written communication skills with a customer-service focus
- Maintain a positive working environment that embodies a culture of aspiration, caring, empowerment and a #oneteam approach with the ability to build an effective team; excellent team player who encompasses the management skills to motivate, enthuse and lead teams; accountable, dependable and strong commitment
- Excelled organizational and time-management skills with the ability to multitask, meet deadlines and work effectively in a fast-paced environment with competing priorities
- Self-starter with common sense and able to act on own initiative
- Ability to apply clear and consistent performance standards as well as identify concerns and resolve decisively and objectively