Sr. Manager- Data Management

Kyowa Kirin is a fast growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four areas of unmet need: oncology, nephrology, immunology and CNS/movement disorders. The North America organization includes three offices (in New Jersey and California) that focus on drug discovery, product development, and commercialization. Together, we work as a close-knit team to understand clinical needs and advance innovations that can have a profound impact on patient lives.

As a patient centric organization that strives to deliver innovative medicines to meet unmet needs, we feel that it is critical to follow the safety guidelines defined by CDC and OSHA. We believe the COVID-19 vaccine is the best way to manage COVID risk to you, your colleagues, your family and our society. With that in mind, we are taking the essential step to ensure the safety of our employees during this health crisis by requiring all US employees, temporary workers, agency employees and independent contractors to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. In accordance with applicable law, individuals may seek an accommodation for medical or disability-related conditions or sincerely held religious beliefs.

Summary:

Responsible for managing and overseeing all aspects of data management (DM) for assigned NA/EU development projects, including selecting and managing DM vendors, managing tasks performed by vendors,  assuring data quality, interfacing with in-house staff and maintaining global data standards and department procedures.

Essential Functions:

•    Ability to lead and support multiple global studies concurrently with minimal oversight by functional manager.
•    Identify, evaluate and select CROs to provide project data management activities. Review and/or create Requests for Proposal(s); Participate in vendor audits; and Document specific requirements as appropriate (e.g. systems, vendor SOPs/WI’s).
•    Ability to identify and create DM process improvement methods (e.g. SOP and WI’s).
•    Proven ability to closely collaborate with cross-functional team members (internally and externally).
•    Strong cross-functional understanding on the impact of data management processes to other stakeholders.
•    Strong understanding of regulatory guidelines (and the related issues) (e.g. ICH/GCP) and the connection to DM deliverables (e.g. data quality and data integrity).
•    Good understanding of coding (MedDRA and WHO Drug dictionaries) to check consistency codes.
•    Strong familiarity with CDISC (CDASH/SDTM).
•    Strong knowledge of EDC systems, specifically Medidata RAVE.
•    Good understanding of SAS programming.
•    Knowledge of BI Tools, especially Tableau.
•    Assist Head of Data Management in identification, creation and maintenance of department procedures: Lead departmental initiatives related to process building/improvement and integration of new technology.
•    Participate as a subject matter expert in Regulatory Submissions and Regulatory Audits.
•    Coordinate and liaise with Japanese HQ as necessary, regarding global Data Management procedures, process and standards.
•    Remain visible within the scientific community as needed (e.g. presentation/publication). 
•    Mentoring of other internal DM members.

Project Team Responsibilities:
•    Oversee all aspects of data management tasks performed by vendor, which include but not limited to: Review CRF, database and dataset structure, Data Management Plan, Data Review Guidelines and edit specifications; Assure dictionary versions are correct; Request specific project tracking reports; Qualify vendor personnel; Review queries; Oversee change order activities; Perform internal activities associated with database lock at vendor (e.g. SAE reconciliation, dictionary term reconciliation, external vendor reconciliation and document collection).
•    Interface with internal and external staff: Participate on Project Teams; Review protocols, statistical analysis plans, monitoring guidelines and Clinical Study Reports; Work closely with Medical Monitor(s) to review CRF coding for logic, consistency and medical appropriateness.
•    Assure all clinical data is properly collected, cleaned and formatted, to assure data quality and data integrity for proper analysis and interpretation required for inclusion into reports and regulatory submissions.
•    Work closely with DM vendors to ensure timelines are met and communicate to Project Management as appropriate in order to achieve KPIs.
•    Archival of end-of-study documents as appropriate.

Requirements:

Education
-    Master’s Degree in Science, Technology, Engineering, or Mathematics, and/or equivalent knowledge and experience

Experience
-    8+ years of Clinical DM experience.

Technical Skills
-    Proficient in systems and tools used in clinical trials (EDC, BI tools).
-    Proficient in Microsoft tools (Excel, Word, PowerPoint, etc.)

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 135 Route 202/206, Suite 6, Bedminster, NJ 07921 USA and can be contacted by emailing [email protected]. Controller’s data protection officer can be contacted at [email protected]. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at [email protected].

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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