Sr. Clinical Trials Management Associate
Proclinical is currently recruiting for a Senior Clinical Trial Management Associate with a global leading pharmaceutically company located in the South San Francisco, CA. Successful candidate will coordinate and supervise all aspects of a clinical study.
- Monitor clinical trial sites.
- Assists Clinical Program Manager in overall study management.
- Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports.
- Maintains study timelines.
- Contributes to development of study budget. Contributes to development of RFPs and participate in selection of CROs/vendors.
- Manage CROs/vendors.
- Coordinates review of data listings and preparation of interim/final clinical study reports. May contribute to development of abstracts, presentations, and manuscripts.
- Ensure effectiveness of site budget/contract process.
- Participate in meetings and conference calls with CROs, vendors, and multi-functional teams.
- May be asked to train CROs, vendors, investigators, and study coordinators on study requirements.
- Assist in determining the activities to support a project's priorities within functional area. Under supervision, may design scientific communications within the company.
Skills and Requirements:
- At least 5 years of pharmaceutical experience, at least a Bachelor's degree, knowledge of FDA/EMEA Regulations and ICH/GCP Guidelines governing the conduct of routine clinical trials, and experience managing CROs/vendors.
- Strong analytical, conceptual and business judgment skills.
- Excellent planning and organizational and administrative skills to demonstrate initiative.
- Demonstrate core values of strong team work and accountability with ability to prioritize competing timelines and deliver excellent results while working independently
- Significant technical expertise and learning ability with demonstrated flexibility required to maintain pace in the market.
- Exceptional communication skills both oral and written.
- Excellent problem solving ability.
- Effective project and time management skills.
- Tenacity and perseverance to ensure high level customer service.
- Teamwork is a mandatory requirement as it involves building and maintaining internal/external networking and cross-functional collaboration.
- High sense of urgency and commitment to excellence in the successful achievement of objectives and program execution.
- Ability to demonstrate good business judgment.
- Working knowledge of FDA/EMEA Regulations and ICH/GCP Guidelines governing the conduct of routine clinical trials.
- Working knowledge of MS Word, PowerPoint, Outlook, and Excel.
- Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
- Ability to develop tools and processes that increase measured efficiencies of the project.
- Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
- Must have a general understanding of functional issues and routine project goals from an organizational perspective.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Catherine Nguyen at (+1) 215-531-5643 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.