Translational Sciences Operations Manager

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 Translational Sciences Operations Manager plays a critical role in supporting biology research and clinical biomarker programs by driving the execution of biomarker operational plans. This individual will collaborate in a cross-functional, matrixed environment to help deliver high-quality translational data in human clinical studies.

Essential Functions of the Job (Key responsibilities)

* Play a key role in the communication and integration of translational sciences objectives with clinical study team members during protocol development and execution.

* Serve as a member of the Translational Sciences clinical study start team; support the tactical execution of biomarker sample collection and analysis during clinical protocol development, study start-up and amendments, including contribution to and review of protocols, lab manuals, and central laboratory specification documents and communicate information as required to other departments within Incyte and CROs (if appropriate); take part in program meetings with central lab, clinical, operations and data management.

* Contribute to activities involving the Data Management team, including eCRF set-up, database build for sites, and sample tracking/reconciliation

* Contribute to the efforts to standardize nomenclature, pictograms, sample handling instructions and resources for all the central labs to provide consistency across studies.

* Develop comprehensive training guides for study setup that assist in the review and completion of critical trial documents, including central lab specification documents, lab manuals, and requisition forms.

* Review, edit, and ensure the accuracy, compliance, and clarity of informed consent forms for clinical research studies.

* Participate in vendor meetings to stay informed of current and upcoming projects, new technologies and vendor offerings. Attend off-site meetings as needed.

* Solve problems independently, contacting internal or external clients as needed.

* Must be able to prioritize workload in response to the specific needs of numerous protocols and departments.

* Maintain awareness of local and international regulations as pertains to protecting the privacy of personal information that may be associated with clinical samples.

* Participate in process improvement initiatives. Plan and implement procedures and systems to maximize operating efficiency.

Qualifications (Minimal acceptable level of education, work experience, and competency)

* Scientific background in life sciences (eg. BS, RN, Med Tech) or equivalent.

* Minimum 5-7 years of relevant experience in clinical drug development or clinical trial operations, including familiarity with biomarker, pharmacokinetic, or immunogenicity sample processes including sample collection procedures and logistics considerations, and exposure to informed consent language specific to the handling of human tissue specimens

* An understanding of the drug development process and familiarity with clinical labs

* Experience working with CROs

* Demonstrated knowledge of ICH and GCP

* Advanced skills in Microsoft Office programs, Smartsheet as well as good working knowledge of electronic data systems and controlled sample management systems

* Detailed and precise record keeping skills are essential as well as the ability to track and resolve issues

* Excellent teamwork and ability to collaborate with cross functional teams

* Strong interpersonal, written and verbal communication skills

* Superior time management, planning, and organizational skills

* Proficiency in creating detailed and user-friendly documentation

* Capable of working on multiple projects simultaneously, organizing workload to meet deadlines and working both independently and collaboratively to achieve goals

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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