Senior Manager Data Management

Daiichi Sankyo Europe

Multiple Locations, Europe

Purpose of the function:

The Senior Manager Data Management, is accountable for the end-to-end delivery of data management services for assigned drug development programs collaborating with study teams, line functions, CROs, external vendors, and partners to ensure high quality deliverables on time and within budget to support drug development processes and global submissions. This position provides leadership within Data Management by partnering with internal and external stakeholders to optimize data management technology, processes, and standards. Additionally, this position develops/proposes strategies within Data Management and collaborates cross-functionally to ensure successful outcomes for programs. This position manages Data Management direct reports and/or leads initiative teams to achieve departmental objectives. This position may direct more than one program concurrently.

Roles and Responsibilities:

Leadership, Direction, and Strategy:

Executes DM departmental strategy at the program level and implements supplemental program-specific solutions as required; ensures consistent execution of data management activities across the program.
Is accountable for data management deliverables for all studies within the program meeting quality, time and cost expectations and regulatory requirements from study start-up through study closure.
Leads development and implementation of standardized operating procedures and standardized operating instructions across programs and organization.
Proactively identifies and manages risks to data quality, data integrity, and timelines at the program level with respect to regulatory submissions.
Builds business relationships with other line functions; is an ambassador and DM SME.
Functions as the DM escalation point for studies in the program; proactively develops solutions within and across functions and resolves complex issues.

Project Management:

Is accountable for the completion of Data Management activities for assigned programs (e.g., study startup, study conduct, study closeout, under the outsourced and in-house operating models.
Is responsible for oversight for Data Management resources, CROs, and vendors to ensure compliance with the protocol, Policies, SOPs, external/internal standards, program standards, Good Clinical Practices (GCPs), applicable regulatory requirements, and other relevant guidelines.
Communicates with DM leadership and program’s cross-functional leadership and DM staff regarding program-level goals, expectations, timelines, overall status, risks, data trends, and issues.
Ensures alignment of study deliverables and timelines with program timelines and expectations.

Functional Expertise:

Evaluates vendor Scope of Work and participates in vendor Request for Proposal process, bid defense meeting, and selection of vendors.
Provides guidance to cross-functional planning to set data management deliverables at the program level.
Promotes adherence of DM processes, methodologies, data standards, and technologies ensuring quality delivery of DM services.
Reviews and endorses proposals for new data standards within the program originating from study teams.
Provides guidance and expertise on data management of complex study designs, technology usage, system integrations, and disease-area specifics to study teams.

Operational Efficiency/Continuous Improvement:

Provides leadership within Data Management by partnering with internal and external stakeholders to optimize data management technology, processes, and standards (improving quality/inspection readiness, decreasing cycle times, and reducing costs).
Increases awareness of data management emerging trends, technology, and best practices within Daiichi Sankyo to achieve operational excellence
Leverages comprehensive Data Management expertise to promote and incorporate data management best practices across the Clinical Trial lifecycle.

Personal skills and professional experience:

Bachelor's Degree or higher in life sciences or related field.
9 or More Years experience in Clinical data management and/or related work experience in a medical device, biotech, or pharmaceutical company, or similar environment (e.g., CRO); oncology, immunology, or complex disease clinical trial experience required.
4 or More Years combined experience managing people and initiatives; experience overseeing vendors providing data management services.
Proficient in end-to-end clinical trial processes of directing/overseeing data management services and deliverables (e.g., CRFs, edit checks, data review listings, database locks, reconciliation) for multiple studies.
Proficient in Electronic Data Capture, DM review tools, and Microsoft Office applications (e.g., EXCEL, WORD, PowerPoint, etc.).
Able to lead study and initiative teams to achieve high-quality, on-time deliverables.
Effective management and development of people.
Demonstrated communication, problem-solving, and collaboration skills with people at different levels and from different disciplines and cultures.
Demonstrated excellent project management skills.
Demonstrated negotiation and conflict resolution skills.
Knowledge of clinical trial operations, clinical trial data flow, pharmacovigilance, and biostatistics.
Knowledge of industry best practices in clinical data management and relevant Good Clinical Practices (GCP) and regulatory requirements.
Knowledge of clinical coding.
Knowledge of CDISC – specifically SDTM.
Experience working with studies using local lab data management processes.
Experience in continuous improvement, change management, and risk management