Manager, External Data Acquisition and Management in Basking Ridge at Daiichi Sankyo

Date Posted: 3/10/2023

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Basking Ridge
  • Experience:
    Not Specified
  • Date Posted:
    3/10/2023
  • Job ID:
    R1476

Job Description

Summary:


The Manager, External Data Acquisition and Management is a member of the Biostatistics and Data Management team and serves as a subject matter expert for the acquisition, oversight, and management of external data for all clinical studies. External data may include partner generated datasets and other clinical trial data coming into Daiichi Sankyo based on established data transfer agreements with our partners in accordance with industry standards and regulatory requirements. This position will establish and manage accountability for the quality and integrity of all in-bound external data transfers and coordinate the delivery of external data with our partners consistent with the established data transfer agreements. In addition, this position will also establish traceability of data receipts and improve visibility across datasets collected from various sources for each study. Besides, the scope of work includes working closely with members of the Biostatistics and Data Management teams, external partners, and other stakeholders.

Responsibilities

- Leadership, Direction, and Strategy:

Establish and manage accountability for the quality and integrity of all in-bound data transfers and coordinate the timely delivery of all external data in line with the established data transfer agreements.


- Project Management:

Manage all quality deliverables for the timely acquisition and management of external data in accordance with our GSOP/GSOI, External File Transfer Specifications, and Electronic Data Transfer Specifications and maintain inspection readiness of the documents in partnership with DS partners and the study data managers. Ensure effective quality oversight on the deliverables from our CRO Partners and Functional Service Providers engaged in the acquisition and management of external clinical data. Proactively identify and resolve issues that may influence and/or impact study quality and other deliverables. Work closely with the study teams to develop specifications, support adhoc external data reporting needs, and manage quality expectations in partnership with internal and external stakeholders, as needed. Partner with the study data managers to facilitate in the quality review and acceptance of the external data in Clinical Data Repository.


- Functional Expertise:

Serve as an external data acquisition and integration subject matter expert and provide oversight and technical support in the planning, setup, acquisition, and integration of external data. Contribute to improving the foundational capabilities for the acquisition and management of external data including establishing supporting processes and tools. Improve the review and coordination of the data transfer agreements with our partners for end-to-end improved quality, consistency, and integrity for all studies. Establish log/traceability of data receipts, data integrity verification, and improve visibility of datasets collected from various sources for each study. Establish appropriate work procedures/guidance, logs, templates, quality procedures, risk mitigation procedures, and achieve consistency and transparency across programs. Implement quality-by-design approaches to confirm the quality, integrity, and fit-for-use of the external data based on appropriate and/or established data-cut-off as a pre-requisite for database lock. Support preparations and follow-up actions related to internal audits and health authority inspections. Contribute to the development, maturity, and consistent use of external data standards across DS clinical programs. Participate in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies, work procedures, external data oversight plan, and guidelines.


- Operational Efficiency / Continuous Improvement:

Identify opportunities for continuous process and technology improvements, defining and implementing the changes for improved quality, integrity, and compliance.Establish metrics to help determine the efficiency, quality, and consistency of non-CRF data transfers through study close-out.


Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.


Education Qualifications (from an accredited college or university)

- Bachelor's Degree in life sciences or related field required
- Master's Degree preferred


Experience Qualifications

- 4 or More Years Minimum of 5 years of Global Clinical Trial Experience in the device/pharmaceutical/CRO industry; expertise in best practices of external data acquisition, integration, and management; knowledge of industry standard clinical technologies including CTMS, EDC, Clinical Data Repository; knowledge of CDASH and CDISC data standards; knowledge and understanding of data acquisition and integration tools and technologies required