Manager – Clinical Affairs | Illumina | US – North Carolina – Remote, Jobs in the USA. Biotechnology Jobs, Bioinformatics Jobs
This role will join the Clinical Affairs department and will manage the planning, preparation for, implementation and monitoring of multiple clinical trials in collaboration with the clinical program manager and the project team to meet study enrollment and delivery timelines per applicable regulatory requirements, Good Clinical Practices (GCPs) and standard operating procedures.
- Perform the activities of motivating, monitoring, and managing Clinical Study Sites worldwide and ensure site compliance with protocol and overall study objectives, SOPs, applicable regulations and ICH/GCP guidelines
- Conduct site qualification, site initiation, routine monitoring and study close-out visits and generate the corresponding reports.
- Establish effective relationships with clinical investigators and staff
- Work proactively with the data management team to identify and resolve data discrepancies
- Track study progress using study tracking tools, ensuring timely and quality updates to the system used
- Oversee the design and development of clinical trial protocols, case reports forms, and other study documentation
- Establish and maintain the trial master file (TMF)
- Manage contract negotiations, site budgets and payments as needed
- Manage CRO and vendor management, as needed
- Develop strong working relationships and maintain effective communication within the Clinical Department as well as other functional departments within the company
Listed responsibilities are essential, but not an exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
- Knowledge of GCP, GLP, ICH guidelines and other U.S. and international clinical regulatory requirements
- Demonstrated ability to organize and present scientific information (e.g., clinical study results) to internal and external audiences
- Excellent verbal and written communication skills.
- Excellent organizational, record retention, time management, decision making, customer service, and interpersonal skills.
- Good command of written and spoken the English language
- Plans and makes decisions by considering the impact from all relevant perspectives; able to verbalize decisions in a thorough and effective manner
- Able to proactively identify and address areas of inefficiency and provide creative, successful solutions.
- Holds self and others accountable for adherence to high work and ethical standards
- Flexible; adapt work style to meet department and company needs
- Develops solutions based on limited information and oversight.
- Experience with protocol writing and case report form design.
- Ability to travel as required (up to 80%)
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilitiesIllumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, colour, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.
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