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Senior Clinical Data Management Lead

CR/080487
  • Competitive
  • England, South East, Berkshire, Reading
  • Contract
Orion Group Life Sciences are currently recruiting a Senior Clinical Data Management Lead on behalf of our Multinational Biopharma Client based in Reading on an initial 8-Month contract with potential to extend.
 
Remote Role.
 
Job Description
The Senior Clinical Data Management Lead is responsible for the end-to-end delivery of data management services across single or multi-service clinical projects. This role ensures high-quality data management deliverables are produced on time, within budget, and in line with customer expectations, contractual obligations, and regulatory requirements.
The role provides leadership, technical expertise, and oversight in project planning, execution, financial management, communication, and milestone delivery. The individual may act as a Data Team Lead (DTL), Program Lead, Project Manager for single-service data management projects, and/or a Subject Matter Expert (SME) in specific Clinical Data Management (CDM) tasks or technologies.
 
Key Responsibilities
  • Manage end-to-end delivery of data management services for single and multi-service projects, ensuring quality deliverables are delivered on time, within budget, and to customer satisfaction.
  • Provide comprehensive data management expertise to Clinical Data Management teams to deliver high-quality data management products that meet customer needs.
  • Provide leadership and vision in project planning, execution, close-out, financial management, communication, and milestone delivery.
  • Perform the role of Data Team Lead (DTL), Program Lead, Project Manager for single-service data management projects, and/or leadership role in a specific CDM task or technology as required.
  • Comply with Good Clinical Practice (GCP), applicable regulatory guidelines, SOPs, policies, and CDM guidance documents.
  • Serve as primary point of contact for customers on data management deliverables.
  • Provide project management expertise while working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise.
  • Provide justification for and directly negotiate with customers regarding timelines, financials, processes, and resources.
  • Maintain strong customer relationships and ensure open communication to meet contractual obligations.
  • Maintain data management study files in an audit-ready condition.
  • Meet regularly with Data Operations Coordinators and/or data operations team members to ensure milestones meet timelines and quality expectations.
  • Establish and maintain strong communication with data operations teams, functional leads, project managers, and other stakeholders.
  • Serve as escalation point for unresolved data issues and work with customers, vendors, and internal teams to resolve them.
  • Work with functional managers to ensure appropriate resources are assigned to meet project deliverables.
  • Create, review, and approve Data Management Plans (DMPs).
  • Ensure services and quality meet agreed specifications outlined in the DMP and contract/Scope of Work (SOW).
  • Implement proactive quality management plans across multiple projects or programs.
  • Track service performance, identify root causes of issues, and implement remedial actions.
  • Identify opportunities to improve service delivery and lead change initiatives across multiple projects or programs with minimal support.
  • Ensure timely follow-up and resolution of compliance issues.
  • Provide leadership and expertise in specific CDM tasks or technologies.
  • Train and mentor junior Data Team Lead staff and coordinate the work of more junior DTLs as required.
  • Maintain internal tracking databases and systems.
  • Ensure services and quality meet agreed timelines and deliverables defined in contracts and SOWs.
  • Review financial reports on a monthly basis and participate in project reviews as requested.
  • Identify out-of-scope activities and track change orders through completion.
  • Serve as Project Manager for single-service data management projects, including financial tracking, revenue recognition, and invoicing.
  • Independently bring solutions to the CDM team or department.
  • Lead and/or participate in focus teams, best practice groups, or global or local standard methodology teams.
  • Communicate lessons learned, present at internal workshops, professional conferences, and/or publish articles in professional journals.
  • Participate in the development and implementation of new technologies or tools.
  • Review, provide input on, and maintain operating procedures and work instructions.
  • Perform other duties as directed by the functional manager.
 
Skills
  • Knowledge of medical terminology, pharmacology, anatomy, and/or physiology.
  • Knowledge of operating procedures and work instructions and ability to apply them in practice.
  • Knowledge of Good Clinical Practice and relevant regulatory guidelines.
  • Excellent communication, interpersonal, customer service, and teamwork skills.
  • Strong project management, organizational, and analytical skills.
  • Comprehensive understanding of the clinical drug development process.
  • Extensive data management expertise across the full data management lifecycle, including SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and new technologies.
 
Education & Experience
  • Bachelor’s degree or equivalent in health, clinical, biological, mathematical sciences, or a related discipline.
  • Demonstrated experience leading multiple clinical data management projects through the full data management lifecycle.
  • Proven ability to manage studies and programs independently.
  • Occasional travel required.


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

Aoibhinn Daly Recruitment Consultant

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