Clinical Trial Manager
vor 1 Woche
Summary
The position is accountable for the management of all aspects of Incyte sponsored clinical trial(s). The responsibilities would include (non-exhaustive): (1) Provide input to the overall operational trial(s) strategic implementation; (2) Manage full trial(s) execution within agreed timelines and budget, (feasibility, country identification, sites selection, study documents, recruitment, data cleaning ); (3) Manage the study team and vendors; function as the primary liaison for internal stakeholders, as appropriate
Duties and Responsibilities
- Is accountable to deliver Trial(s) on time, within budget, and with highest achievable quality
- Assists in the review, development and/or writing of clinical trial documents and manuals, including but not limited to Protocol, Case Report Forms, Informed Consent Forms, Study plan, Communication plan, risk Management plan
- Is responsible for feasibility and lead the evaluation and selection of countries and investigative sites
- Select, coordinate and monitor activities of vendors
- Develop and manage trial(s) timelines and budget;
- Coordinate data cleaning and data review
- Ensure set up and maintenance of all systems in order to plan and track trial(s) progress
- Generate reports to update management on conduct of trial(s)
- Ensure appropriate clinical trial supply plans are implemented and managed
- Develop recruitment plans, riskmitigation plan, monitor and implement contingencies as required
- Participate in monitoring study safety
- Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team
- Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work
- Assist with CRA and third party vendor training on protocols and practices
- Lead the multidisciplinary trial(s) team(s)
- Function as the primary contact for trial(s) between Drug Development and other departments;
- Assume responsibility to participate as a member of working groups and perform special projects, as assigned
- Ensure adherence to Good Clinical Practice and all applicable local and international regulations.
Requirements:
- BS/BA degree or a relevant degree with strong emphasis on science;
- Minimum of two years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of multinational clinical trials
- Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience
- Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.
- Demonstrated leadership and problem solving skills
- Experience in executing a wide range of clinical trial activities (from initiation to clinical study report)
- Used to work in a multidisciplinary setting, strong cooperative team player, ability to be flexible and adapt to a changing environment
- Good planning, prioritization, problem solving and organizational skills; strong customerorientation, used to work independently
- Strong communication skills, used to communicate with a broad range of stakeholders and to build strong positive relationships
Disclaimer:
The above statements are intended to describe the general nature and level of work performed by employees assigned to this job.
They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.We Respect Your Privacy
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data.
You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte's data protection practices here.By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).
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