Job Description

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group\xe2\x80\x99s 2025 Vision to become a \xe2\x80\x9cGlobal Pharma Innovator with Competitive Advantage in Oncology,\xe2\x80\x9d Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

JOB SUMMARY

The Manager, Laboratory Data Management, is accountable for delivery of clinical lab data management services for assigned programs, collaborating with program teams, CROs and other vendors, and partners to ensure high quality coding deliverables are on time to support drug development processes and global submissions. This position also partners with internal and external stakeholders to optimize lab result collection, cleaning, and reporting technology, processes, and standards. This position may manage multiple programs concurrently. This position will manage lab data analyst resources of assigned studies.

This position requires strong technical skills in working with clinical laboratory data from local and central laboratories. This position requires solid verbal/written skills, analytical, organizational, and interpersonal skills and works effectively with people at different levels and from different disciplines and cultures. This position requires a demonstrated ability to manage/lead people and a variety of projects concurrently. Additionally, this position possesses working knowledge of clinical lab data collection and reporting, industry best practices, and relevant regulatory requirements. This position has experience working within the medical device and/or pharmaceutical industry across complex disease areas, and experience with regulatory submissions and inspections. This position requires skills in working in a fast-paced environment, continuous improvement, project management, change management, and risk management.

Responsibilities

Leadership, Direction, and Strategy:

• Is responsible for lab data management deliverables for assigned programs meeting quality and time expectations for both in-house and outsourced studies.
• Collaborates with Lab Vendors (Central & Local) for driving lab data planning, data collection, and maintenance activities aligning with Daiichi Sankyo protocol requirements.
• Partners with Study Data Manager to identify, evaluate and resolve laboratory data specific issues and risks and providing working solutions for delivering quality lab datasets.
• Manages Daiichi Sankyo standard local lab information Global Lab Analyte Mapping (GLAM) file and standard LNR Worksheet template.
• Provides input into business process/technical expertise on best practices and new and emerging processes related to laboratory data collection and management.
• Instructs Lab Vendors and/or CROs on Daiichi Sankyo lab data standards and related Daiichi Sankyo lab data processes.
• Reinforces adherence to Daiichi Sankyo lab data standards to Daiichi Sankyo program teams, ensures consistency in understanding and implementation of lab standards across a program.
• Reviews resource needs and utilization of Clinical Lab Data Analysts across assigned program(s).
• Monitors quality of deliverables produced and escalates performance or quality issues. Participates in individual performance reviews if required.
• Participates in audits and inspections to provide study and/or program-level information on clinical lab data processing as needed.

Project Management:

• Is responsible for on-time completion of lab data management activities under the outsourced and in-house operating models.
• Participates in the management of lab vendors to ensure quality and accuracy of transfer agreements/specifications and data transfers.
• Ongoing review of LNR collections process, trend identification, and timely availability of data prior to deliverables to ensure process consistency and quality across all programs.
• Complies with the protocol, Policies, SOPs, external/internal standards, pertinent Good Clinical Practices (GCPs), applicable regulatory requirements, and other relevant guidelines.
• Proactively identifies potential risks to clinical laboratory data quality and timelines for assigned programs and escalates issues to Study Data Manager to gain resolution.

Functional Expertise:

Study Start-Up

• Reviews and contributes to the following study team cross-functional planning documents for lab data collection processing and reporting such as ECRF specifications, listing specifications, Data Management Plan, Protocol Deviation Plan, and vendor transfer agreements.
• Ensure alignment with SDM on timelines and duration of study deliverables.
• Ensure appropriateness of lab test collection in accordance with the protocol requirements and any specialty assays/panels when required.
• Reviews and approves study-specific Lab Normal Range (LNR) worksheet and alignment with protocol.
• Serve as an SME of laboratory data by providing guidance to study team members to develop appropriate study level lab eCRF, CCGs, Edit Checks, electronic file transfer specifications, etc. to ensure the quality/completeness of lab reference ranges and results data.
• Review findings of User Acceptance Testing for lab eCRFs and new elements of the GLAM file to ensure adherence to lab data standards and fit for purpose laboratory data collection.
• Review and approve specifications and production outputs for laboratory data cleaning listings.

Study Conduct

• Responsible for review of local lab reference ranges, ensuring the scientific validity of ranges, units of measure and conversion algorithms for each parameter at Global/Enterprise level.
• Maintains corporate dictionaries for laboratory sites, analytes, units of measure and ranges including complying to CDISC/SDTM standards; submits requests for new analytes and/or units; performs user acceptance testing of these additions.
• Review and assess unit requests from study teams and suggest new units as appropriate.
• Responsible for QC of lab data line listing quality reviews for accuracy, consistency, and completeness within and across programs on an ongoing basis to ensure data quality of clinical trial databases.
• Troubleshoots questionable/missing ranges, units, parameter test names, conversion algorithms and other details related to local lab reference ranges and/ or data and generates queries as appropriate. Consults with Study Data Manager to resolve issues/queries.
• Maintains a Local Lab FAQ log for study teams across programs to identify trends and communicate escalations.
• Monitors lab data and lab normal reference range metrics and trends on a scheduled basis and proactively provides findings to the Study Data Manager.
• Responsible for the filing of Data Management lab documentation and approval/signatures forms in the TMF (Trial Master File) on an ongoing basis according to applicable Daiichi Sankyo and regulatory requirements.

Study Closure

• Accountable for ensuring completeness for LNRs and laboratory data meets quality requirements in support of planned analysis.
• Responsible for the final QC of laboratory Data Management documentation and approval/signature forms in the TMF according to applicable Daiichi Sankyo and regulatory requirements.

Operational Efficiency / Continuous Improvement:

• Participates in and supports process improvements to support the collection, monitoring, review, and reporting of laboratory data.

Responsible for laboratory data management procedures and authorships of specification documents to ensure standardization is maintained; develop new standards and practices where needed * Deliver functional training on laboratory data and processes on an ongoing basis.

• Leverages comprehensive Data Management and lab data expertise to promote best practices across the Clinical Trial lifecycle.
• Researches new lab analytes, tests, and methods to facilitate correct laboratory data handling and reporting; keeps current with industry best practices and regulatory requirements for laboratory data.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education

• Bachelor\xe2\x80\x99s Degree or higher In life sciences or related field required

Additional requirements

Lab Certifications:

• MLS (ASCP) and/or MLT (ASCP) preferred

Work Experience

• 5+ years of laboratory background. Strong knowledge of LIMS, specimen management, range of biomarkers tested in the oncology setting, latest and advanced analytical tools and assays.
• Clinical data management experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO); oncology, immunology, or complex disease
• Working knowledge of Clinical trial data systems and/or EDC lab management tools is a plus

Competencies

• Technical skills of clinical laboratory data science including review and troubleshooting of subject lab data pertaining to diverse tests.

• End-to-end clinical trial experience in clinical trial lab data management activities such as data collection design, discrepancy management, data review, reconciliation, database lock
• Proficient in EDC, DM review tools, and Microsoft Office (WORD, EXCEL, PowerPoint, etc.)
• Demonstrated communication, problem-solving, and collaboration skills with people at different levels and from different disciplines and cultures
• Demonstrated project management skills
• Demonstrated negotiation, team building, and conflict resolution skills
• Excellent attention to detail
• Able to work independently; accepts guidance
• Good self-organizational, planning, and time management skills
• Self-directed; able to work independently with openness for guidance and mentoring
• Able to work on multiple studies concurrently
• Able to manage multiple priorities
• Critical thinker
• Willingness to learn
• Ability to function as Lab SME in internal audits and/or regulatory on-site inspections
• Demonstrated proficiency in English \xe2\x80\x93 both verbal and written

Knowledge

• Knowledge of clinical trial operations, clinical trial data flow, and biostatistics
• Knowledge of clinical data management processes in study start-up, conduct, and closure and relevant Good Clinical Practices (GCP) and regulatory requirements.
• Good understanding of basic programming logic
• Exposure to vendor management
• Familiarity with continuous improvement, change management, and risk management
• Familiarity with different software systems and technologies used in clinical data management
• Awareness of complex clinical trial designs
• Awareness of regulatory submissions, regulatory on-site inspections, and internal audits

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Daiichi Sankyo