Associate Director, Clinical 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 disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

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

Essential Functions:

•    Strong understanding of Risk Based Quality Management.
•    High sensitivity to industry trends and the ability to leverage them in business
•    Accountable for all aspects of data management tasks from vendor selection to new drug application.
•    Conducting risk assessments related to data and designing data quality by mitigating risks.
•    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’s data reconciliation and document collection).
•    Collaborating with an external vendor to create a Data Transfer Agreement.
•    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.
•    Responsible for budget planning for DM-related tasks, department budget planning, and budget performance tracking.
•    Supervise DM staff and manage DM resources
•    Support sub-function head of data management in hiring data managers
•    Negotiate with partner companies to obtain trial data. If there are gaps, develop alternatives to complete the submission materials.
•    Participate as a subject matter expert in Regulatory Submissions and Regulatory Audits.
•    Meet and discuss with Japanese HQ regularly, regarding global Data Management procedures, process and standards.
•    Staying updated on industry trends, proposing new Data Management strategies, and executing them independently.

Requirements:

Education
Bachelor's degree in science, Technology, Engineering, or Mathematics, and/or equivalent knowledge and experience

Experience
•    Minimum 10 years’ Clinical DM experience.
•    Minimum 5 years’ pharmaceutical company experience.
•    Minimum 2 years’ people management experience 
•    Multi Regional Clinical Trial experiences
•    Experience in hematological cancers or bone/mineral studies is highly desirable
•    Subject Matter Expert (SME) in FDA or EMA Inspections is highly desirable.

Technical Skills
•    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).
•    Strong understanding of Risk Based Quality Management.
•    Good understanding of Medical coding (MedDRA and WHO Drug dictionaries) to check consistency codes and upgrade.
•    Strong familiarity with CDISC (CDASH/SDTM).
•    Good understanding of Computerized System Validation
•    Proficient in systems and tools used in clinical trials (EDC, BI tools).
•    Proficient in Microsoft tools (Excel, Word, PowerPoint, etc.).
•    Basic knowledge of Decentralized Clinical Trials(DCT) and AI(Artificial Intelligence)

Working Conditions:

Normal office environment with prolonged sitting and extensive computer work. Work in the