Associate Director, Data Management

Location: Woburn, Massachusetts
Job Type: Permanent
Specialisation: Life Sciences
Salary: Negotiable
Reference: BBBH2162_1635849194
Contact: Jessica Charles
Email: email Jessica
Role: Associate Director, Data Management

I'm working with a company to advance the science of oncolytic immunotherapy improving both existing therapies and helping treat more patients with a variety of tumour types. Their oncolytic immunotherapies have the potential to redefine the cancer treatment paradigm through igniting a patient-specific anti-tumour immune response both locally at the site of the injected tumour and systemically throughout the body.

The Associate Director (AD) of Data Management (DM) is responsible for clinical data management activities for all phases of clinical trials and programs. This role participates in or oversees data management staff in cross functional teams, with both internal and external collaborators or contract research organizations. Also serves as the internal expert in all areas of clinical data management processes and technology.

Responsibilities:
Review/Management of DM activities in vendor proposals, budgets and scopes of work.
Reviews and provide input into protocols, SAP, IB, CSR and other clinical study documents during development.
Responsible for DM vendor oversight at program level.
Function as internal DM Study lead, overseeing all data management activities performed by CROs including generation and review of metric status and patient tracking reports; Work to ensure on-time achievement of major data management deliverables and milestones in coordination with other functions.
Review and manage key documents such as data management plan, guidelines for CRF completion, data review, SAE reconciliation, and data audits. Provide DM-level review and input on all study medical coding.
Following CDISC conventions, oversee or perform eCRF design and annotation, database design specifications; Develop or oversee CRO generation of data edit check specifications; Participate in user acceptance testing (UAT) of the clinical database, including edit check testing
Create specifications for internal study team data review plan and guidelines and Protocol Deviation specifications document, with input from study team
Lead internal study team in data review; Perform data review for quality issues and general data trends; generate queries as necessary. Provide guidance to others on program-level internal data review standards.
Work with SAS and/or clinical systems programming to produce in-process data reports and data visualization tools to facilitate decision making on clinical trials (e.g., safety reviews). Provide input on standard tools and reports.
Give Data Management presentations and/or training at investigator or other meetings
Lead and/or participate in development and implementation of departmental initiatives. Develop or improve data management SOPs and guidelines
May have direct reports; serve routinely as resource or mentor for other DM personnel. Partner with appropriate stakeholders for issue resolution


Requirements:
10+ years of relevant work experience with a focus on data management
Deep knowledge of clinical data management outsourcing with full-service global CROs and niche service providers
Expertise in clinical oncology indications, end points, data flow, data integrity, standards and data quality
Strong project management skills and ability to lead and collaborate effectively with cross-functional teams

If this sounds of interest, please reach out to me at 01737 236729 /