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Clinical Trial Manager/Sr. Clinical Trial Manager, Hemoglobinopathies Cambridge United States, London United Kingdom, Basel Switzerland,
Posted on : 26 April 2017
- Reporting to the Head of Clinical Operations, this individual will have primary responsibility for trial management within hemoglobinopathy indications.
- The successful hire will adhere to best practices ensuring rigor and high quality execution of clinical trials from FIH through commercial marketing authorization.
- This person will manage cross functional relationships with internal and external stakeholders and be the clinical operations representative to the hemoglobinopathy program clinical sub-team. This individual will be hands on with trial sites fostering relationship development with KOLs.
- This is a high visibility position with great impact potential.
- Responsible for managing CROs/vendors for assigned trials ensuring adherence to defined scope of work and budget
- Identify issues and implement solutions to ensure timelines are maintained
- Develop and maintain tracking tools for clinical trials including study and monitoring visits, sample tracking, data entry and action item progress
- Assist with the drafting of protocols, informed consent forms, study operations guidelines and other study plans
- Develop trial specific training tools for site utilization
- Oversee maintenance of the eTMF
- Work with company financial management to reconcile monthly actual and forecast budgets
- Monitor and/or co-monitor clinical trial sites
- Plan and coordinate advisory boards, investigator meetings and CRA trainings
- Work collaboratively with supply chain to ensure seamless collection/manufacture/shipment of cells
- Develop project-specific procedures and processes
- Recommend and follow up on corrective actions
- The candidate must maintain a high standard of professionalism, and confidentiality in this role and must be able to problem solve, communicate effectively, and trouble-shoot creatively
- BS/BA/BSN health/science related field preferred
- Minimum 3-4 years relevant industry experience including at least 1 year of trial management experience.
- Excellent communication, writing and presentation skills
- Demonstrated ability to work independently as well as in a team environment and seek resources as necessary.
- Ability to assess complex issues and propose viable solutions
- Demonstrated ability to lead and organize team meetings
- Ability to foster effective relationships with vendors, investigators and colleagues
- Ability to contribute technical expertise to the various aspects of the clinical trial process.
- Knowledge of industry standards as applied to ICH guidelines, GCPs and the CFR
- Proficiency in study monitoring activities
- Knowledge of the infrastructure and operational characteristics of CROs and centralized services.
- Demonstrated effective time management skills
- Must be willing to travel domestically and internationally up to 15-20%
- MS or advanced degree
- 5 or more years in a Clinical Operations Management role
- Global trial management experience
- Prior Clinical Monitoring and/or CRO experience
- Knowledge of First in Human trial management
- Experience with hematology and/or transplant
- Experience with cellular therapy trial management
- Adaptability/Flexibility The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands
- Communication and Teamwork The ability to effectively express ideas in written and oral context. The ability to work co-operatively with others; the genuine desire to be a part of a team and contribute to organizational and team goals.
- Effective Planning - Embedding discipline and thoroughness in our approaches.
- Perseverance Pursues tasks with energy, drive and initiative, even in the face of adversity.
- Problem Solving The ability to understand a situation, task or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related.
- Relationship Building Builds and maintains productive working relationships across a diverse spectrum of people.
Cambridge MALondon UKBasel Switzerland
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