We are currently seeking qualified candidates for a Clinical Trial Manager role with a global leader in in-vitro diagnostics. This is a permanent position that will be based out of the Bay Area, California, USA.
PURPOSE
The Clinical Trial Manager will represent the Clinical Affairs department in the management of clinical trials and marketing evaluations associated with the Company’s IVD products. Anticipated clinical studies will validate additional content, features, and intended use claims for the existing product portfolio as well as study the technical feasibility and/or clinical utility of new products in development.
Responsibilities of the Clinical Trial Manager include writing and filing study documents, ensuring supply of materials and information to study sites, responding in real-time to site issues or concerns, reviewing data as they are reported (expected daily), ensuring sites are compliant with the regulations and the study protocols, raising data queries and ensuring timely responses from sites, reviewing protocol deviations and assessing their impact on clinical trial data, reviewing statistical analysis reports, and assisting in writing clinical study reports.
This position requires a thorough understanding of clinical trials for in vitro diagnostic (IVD) products, including the US regulations and Good Clinical Practice (GCP) guidelines. As this is a customer-facing role, it requires a confident communication style, including the ability to listen and respond in a clear and logical manner.
RESPONSIBILITIES
- Work closely with the head of Clinical Affairs to oversee clinical sites and manage clinical trials
- Represent Clinical Affairs in project-specific working groups and teams
- Write clinical trial protocols and clinical study reports
- Work with the Clinical Research, Marketing, and Development teams to design and manage early product evaluations with key investigators
- Write clinical trial-specific documents including but not limited to: protocols, case report form completion guidelines, monitoring plans, source worksheets, specimen management plans, study manuals of operations and clinical study reports
- Participate in the identification, qualification, initiation, monitoring, and close-out of clinical trial sites
- Manage inventory of investigational product and ensure sites are properly supplied
- Oversee site operators and provide monitoring to trial or evaluation sites
- Review and contribute to statistical analysis plans and statistical analysis reports
- Review clinical data for accuracy and raise queries as needed
- Work with data management and biostatistics to ensure timely receipt, review and completion of data for clinical databases
- Manage, track, and report all protocol deviations and work with Director of Clinical Affairs to assess impact to study data
- Perform other tasks and duties as assigned
EDUCATION, SKILLS & EXPERIENCE
- BS degree in biology, biochemistry (or a related field) or a minimum of five years of experience in an assay development or diagnostic product-related field
- 7-10 years of experience managing clinical trials either as a clinical research monitor or clinical research associate (IVD experience preferred)
- Strong understanding of GCP/ICH requirements, with an emphasis on US clinical trials management
- Strong understanding of automated platforms and software
- Strong listening and communication skills
- Ability to effectively communicate with all personality types
- Capable of multitasking and being an effective time manager
- Polished professional with strong interpersonal, presentation, grammatical, spelling, proofreading, telephone etiquette, and social skills
- Basic knowledge of all Microsoft Office products (Excel, Outlook, PowerPoint, and Word)
- Proficiency in using desktop publishing software and database programs, as well as proficient internet research skills
- Ability to use diplomacy and handle sensitive and confidential matters discreetly while exhibiting honesty, integrity, discretion, and sound judgement at all times.
- Good organizational, problem-solving, and analytical skills
- Ability to manage priorities, projects, and workflow
- Attention to detail, with a commitment to excellence and high standards
- Knowledge of general office concepts, practices, and procedures
- Ability to deal effectively with a diversity of individuals at all organizational levels
- Ability to work on projects with general direction and minimal guidance, managing multiple priorities through to completion in a timely manner
- Versatility, creativity, flexibility, and latitude, with a willingness to work through changing priorities with enthusiasm.
- Proactive, motivated, and focused team-player attitude, self-sufficient, and prepared to go “above and beyond” on a regular basis.
- Creative, innovative individual who works well in a fast-paced environment
