at Incyte Corporation in Wilmington, Delaware, United States
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function)
The Manager, Study Start-Up supports end-to-end site start-up from feasibility to site activation serving as the primary point of contact for the site and the study team under the guidance of the Associate Director of Global Study Start-up and Central Services. The manager supports site level feasibility assessments, coordinates site identification at a country and regional level, supports site qualification, and supports site start-up activities.
Essential Functions of the Job (Key responsibilities)
Serve as primary point of contact to study team on end-to-end start up activity.
Lead the Study-Start-up team meetings.
Utilize Study Start-Up tools to track activities and develop reports.
Oversee Feasibility activities including the negotiation and collection of Confidential Disclosure Agreements and the collection and analysis of Feasibility Questionnaires.
Oversee site contract/budget negotiation led by Site Contract team (Confidentiality Agreement and Clinical Trial Agreements).
Oversee essential documents collection, tracking & review led by Document Management Team.
Support the collection of country and site level intelligence.
Support Institutional Review Board/Ethics Committee and Regulatory Authority submissions.
Complete, manage and/or support country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate sites for a clinical trial as appropriate.
Qualifications (Minimal acceptable level of education, work experience, and competency)
BA/BS degree in Science or related field.
5 - 7 years' experience in site start-up and contract management in pharmaceutical company or in clinical research organization.
Thorough knowledge of applicable regulations, drug development, and clinical trial management procedures.
Strong presentation, documentation, and interpersonal skills.
Proficient in MS Office (Word, Excel, and PowerPoint), MS Project, email, and Internet.
Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.
Excellent oral and written communication skills.
Excellent planning and organizational skills with effective time management.
Excellent interpersonal skills.
Thorough understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel.
Thorough understanding of clinical research principles and process.
Thorough understanding of FDA and/or EU Directives and regulations, ICH Guidelines and country/local regulatory requirements.
Goal oriented, self-starter with proven ability to work independently.
Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.
Comfort with ambiguity; ability to act without having the total picture.
Ability to proactively identify and solve problems.
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.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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We appreciate, celebrate, and thrive on one another’s differences and strengths and are proud to be an Equal Opportunity Employer. By valuing diversity of backgrounds and perspectives and prohibiting all forms of harassment, we are able to promote a collaborative and innovative work environment in which everybody can contribute to their fullest potential.