Clinical Trials Manager
4 weeks ago
Collabera is seeking a highly skilled Clinical Trials Manager to join our team. As a Clinical Trials Manager, you will be responsible for the worldwide execution of all Phase I - IV clinical trials across all our therapeutic areas. You will work with and collaborate with Clinical Operations, Biomarker Sciences, Clinical Pharmacology and other cross-functional team members to ensure all clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of our products.
Key Responsibilities:
- Manage certain components of clinical studies and act as a member of the study team.
- Manage biomarker and bioanalytical vendors.
- Assist in the review of clinical study protocols and other study documents.
- Contribute to process development and/or participate in special projects.
- Participate in strategic initiatives.
Requirements:
- PharmD / PhD with 2+ years' relevant clinical or related experience in life sciences.
- MA / MS with 3+ years' relevant clinical or related experience in life sciences.
- BA / BS / RN with 5+ years' relevant clinical or related experience in life sciences.
Key Skills:
- Demonstrated ability to be a fast learner.
- Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
- Ability to manage any component of full cycle study management, from start-up to close-out.
- Advanced knowledge of study management best practices and tools and has shown ability to apply these to improve study efficiencies and effectiveness.
- Fully understands protocol requirements and effectively articulates and interprets these.
- Thorough knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies.
- Familiar with standard medical / scientific terminology.
- Experience managing the work of external vendors.
- Ability to communicate in a clear and concise manner.
- Ability to support a team-oriented, highly-matrixed environment.
- Ability to execute multiple tasks as assigned.
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