Clinical Operations Support Specialist
2 weeks ago
Position Title: Clinical Project Assistant II
Department: Clinical Operations - Biomarker and Bioanalytical Operations
Role Summary:
In the realm of Clinical Operations, our team is dedicated to the global execution of Phase I - IV clinical trials across various therapeutic areas. We ensure that all clinical studies adhere to established Standard Operating Procedures (SOPs), company policies, and regulatory standards, ultimately delivering timely and high-quality clinical data to support the registration and commercialization of our products.
Key Responsibilities:
- Manage and prepare study-specific data utilizing databases, spreadsheets, and other analytical tools.
- Engage in the quality assurance process for data and documentation.
- Coordinate meeting logistics, including agenda preparation and minute-taking.
- Collaborate with various departments to fulfill assigned tasks effectively.
- Assist in the creation of essential documents and standardized forms.
- Ensure compliance with established practices, policies, and regulatory requirements in all work.
- Work alongside cross-functional teams within Oncology, Inflammation, and Virology therapeutic areas.
- Support sample reconciliation for ongoing clinical studies in partnership with BBOps Study leads, ensuring accurate sample tracking and consent verification.
- Utilize eTMF/Veeva systems to support electronic Trial Master File documentation.
- Participate in presentations as necessary.
Qualifications:
- We value diverse backgrounds and unique contributions in our mission to serve patients. The following qualifications are sought for this role:
- Education & Experience:
- MA/MS/PharmD/PhD with relevant clinical or life sciences experience.
- BA/BS/RN with a minimum of one year of relevant professional experience.
- General knowledge of clinical or business practices is preferred.
- Proficiency in Microsoft Word, PowerPoint, and Excel is essential.
- Strong verbal, written, interpersonal, and presentation skills are required.
Knowledge & Skills:
- Ability to learn quickly and adapt to changing environments.
- Flexibility to shift between projects and provide support where needed.
- Willingness to understand the biopharma industry and our business operations.
- Strong teamwork and collaboration skills.
- Excellent analytical and organizational abilities.
- Familiarity with FDA, EMA regulations, ICH guidelines, and Good Clinical Practice (GCP) is advantageous.
- Proficient in basic office software and tools.
- Clear and concise communication skills.
- Ability to thrive in a team-oriented, matrixed environment.
- Capability to manage multiple tasks effectively.
- Willingness to travel as required.
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