Proclinical is currently recruiting for a Clinical Data Management Systems Manager job at a leading multinational biopharmaceutical company with leading therapies in autoimmune diseases and oncology. They are seeking an individual to bring solid Data Management experience their team at their offices in Uxbridge. This is an exciting opportunity to work for one of the world's biggest biotechnology firms that employs over 17,000 staff globally.
The GSO DM Systems Manager will serve as the Operational Lead for the Electronic Data Acquisition (EDA) and Electronic Data Interchange (EDI) operational areas. This role oversees a team that is responsible for importing data for the company's clinical studies from a variety of external sources including central lab and imaging vendors. The role also oversees the company's execution of database snapshots from the company's Rave clinical trials database for use by Biostatistics. The successful candidate will be adept at managing a high-quality, high-availability technical service area within the clinical trial conduct space.
The primary deliverables for the EDA/EDI operational area include supporting electronic data acquisitions, database snapshots, securing potential unbinding/restricted clinical data, as well as providing datasets or listings for audit support. The operational lead will be accountable for the service delivery oversight and process compliance supported by a Functional Service Providers (FSP).
The position is expected to partner effectively with other DM Systems Leads and cross functional leads (e.g. Data Element Standards Governance, Technical Services, BSM, IS) to pursue opportunities in developing business cases, driving and realizing potential operational efficiencies and effectiveness, and improve delivery cycle time and quality. Also serve as key process expert representing EDA/EDI service remits in support of key process transformation projects, functional governance groups, and/or cross functional systems integrations.
Job Responsibilities:
- Serves as the Operational Lead for the EDA/EDI operational area within the Clinical Study Design & Programming group
- Accountable for quality delivery and competencies within the EDA/EDI service area
- Partner with FSP Operational Lead in maintaining consistent compliance to established company processes and best practices for the FSP deliverables
- Partner with FSP Operational Lead in managing CAPA related to the EDA/EDI quality delivery or compliance issues
- Lead or contribute to key or interdepartmental initiatives / projects with particular focus in system or process improvements
- Serves as the document author for process SOP or manuals and owner for the corresponding companion guides and tools (e.g. templates, checklists etc)
- Facilitate rapid issue resolution through others (internal forces and FSP)
- Effectively partner with cross functional support groups, to address potential systematic or technical vendor quality issues
- Assist in audit preparation and responding to audit findings (internal or external)
- Act as process SME and provide support to internal staff or providers
- Authorize appropriate systems access requests for FSP EDA or EDI staff members
Skills and Requirements:
- Bachelor degree or equivalent in life science, computer science, business administration or related discipline
- Broad and proven experience in life sciences or a medically related field including experience in biopharmaceutical clinical research experience
- Proven experience in Base / Advance SAS programming
- Proven experience in a technical role within clinical data management, clinical development, or IS/IT
- Experience in leading and overseeing a specific operational team or external vendors (internal team, FSP, CRO, central labs, imaging vendors etc)
- Effective partnering and client management skills creating productive engagement capabilities to meet stakeholders and clinical study teams
- Experience and ability creating and effectively presenting concepts and materials to senior management levels
- Candidates will demonstrate project management and technical expertise, attention to detail, and excellent documentation and communication skills
- Has operational experience in handling potential unbinding clinical data and file transfer technologies (MOVEit, box etc)
- Excellent time management and organization skills
- Will have sound problem resolution, judgment, and decision-making abilities
- Will be able to work well in a global team-based matrix environment with minimal supervision
- Working knowledge of industry standards such as CDISC LAB, CDASH and other standards initiatives desirable
- Knowledgeable in Good Clinical Practices, and Global Regulatory regulations as necessary
- Proven capability of overseeing and effective partnership with external vendors or service delivery partners in delivering DM systems support or study deliverables
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sam Walker on +44 203 8569 336 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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