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 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 North America we are headquartered in Princeton NJ with offices in California North Carolina and Mississauga Ontario.

Summary:

The Manager of Data Management is responsible for leading and overseeing all data management activities for assigned projects. This includes the selection and management of external data management vendors supervision of vendor-delivered tasks and ensuring the integrity accuracy and quality of clinical and operational data. The role also involves close collaboration with internal cross-functional teams to establish and maintain global data standards support data governance initiatives and ensure compliance with departmental procedures and regulatory requirements.

Essential Functions:

Independently perform Study Data Management activities ensuring timely and high-quality data delivery.
Support Project Data Management Lead (PDML) activities under the guidance of senior leadership contributing to multi-study or global programs.
Oversee and manage all data management activities performed by external vendors including CRF and database design Data Management Plan development data review guidelines edit specifications database lock including SAE reconciliation external data reconciliation and dictionary term reconciliation.
Review deliverables to ensure adherence to project timelines data quality standards and compliance requirements.
Conduct data risk assessments and design proactive data quality strategies to mitigate risks throughout the study lifecycle.
Ensure that clinical data is collected cleaned and formatted according to applicable standards for analysis reporting and regulatory submissions.
Ensure final datasets meet submission readiness and compliance standards.
Track key data management metrics and timelines; communicate progress and risks to cross-functional teams and project management to ensure KPIs are met.
Collaborate with internal teams and partner companies to gather and verify trial data for submission; propose alternatives when data gaps are identified.
Collaborate with cross-functional teams (Clinical Operations Biostatistics Medical Monitoring etc.) to ensure alignment and efficiency in data management processes.
Interface with internal stakeholders and external partners on protocol review CRF logic and consistency clinical study reports (CSRs) and statistical analysis plans (SAPs).
Participate in discussions with global teams including regular engagement with Japanese headquarters regarding global data management procedures standards and strategy.
Monitor industry trends in data management and contribute to the continuous improvement of processes and tools.
Review and approve appropriate dictionary versions (e.g. MedDRA WHO Drug).
Archival of end-of-study documents as appropriate.

Requirements:

Education
Bachelors degree in Data Management Life Science Technology Engineering Mathematics (STEM) or a related field is required. An advanced degree (e.g. Masters in Related disciplines) is highly preferred.

Experience
Minimum of five (5) years of experience in clinical data management within the pharmaceutical biotechnology or CRO is required.
At least two (2) years of experience in a lead role overseeing study-level data management activities including vendor oversight and cross-functional collaboration.
Proven experience with CRO/vendor management including performance tracking and deliverable review.
Hands-on experience supporting or leading database lock activities query management data reconciliation SAE handling and external data integration.

Technical Skills
Deep understanding of clinical data management principles and regulatory requirements including ICH-GCP 21 CFR Part 11 and data privacy regulations (e.g. GDPR HIPAA) and their connection to data quality integrity and audit readiness.
Strong understanding of Risk-Based Quality Management (RBQM) principles and their application in data management workflows.
Proficient in clinical trial data standards including CDISC CDASH and SDTM and practical application in study design and submission deliverables.
Solid working knowledge of medical coding dictionaries such as MedDRA and WHO Drug including code review consistency checks and upgrades.
Demonstrated expertise in Electronic Data Capture (EDC) systems particularly Medidata Rave; working knowledge of other EDC platforms (e.g. Oracle InForm Veeva) is a plus.
Proficient in clinical data systems and tools such as data visualization/reporting platforms and tools for data reconciliation.
Familiarity with Computerized System Validation (CSV) processes and regulatory expectations.
Strong proficiency in Microsoft Office applications (Excel Word PowerPoint Outlook) with the ability to generate reports dashboards and presentations for various stakeholders.
Basic knowledge of Decentralized Clinical Trials (DCT) models and emerging technologies such as Artificial Intelligence (AI) in the context of data management.
Excellent written oral communication and presentation skills.

Working Conditions:
Requires up to 10% of domestic and international -office presence required at least two (2) days per week in accordance with hybrid work policy. Occasional participation in international calls or meetings outside of standard business hours typically once or twice per week may be required.

The anticipated salary for this position will be$125000 to $140000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience skill set qualifications education (including applicable licenses and certifications job-based knowledge location and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Discretionary Profit Share
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs Sick Days and Volunteer Days
• Healthcare Benefits (Medical Dental Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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 510 Carnegie Center Dr. Princeton NJ 08540 USA and can be contacted by emailing Controllers data protection officer can be contacted at . Your personal data will be processed for the purposes of managing Controllers 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 Controllers 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 .

Recruitment & Staffing Agencies

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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