Data Team Lead

Highly Competitive Salary
  1. Permanent
  2. Validation, Project Management, Operations Management
  3. United States
Everett, USA
Posting date: 20 Oct 2020
EN.DM.33555B

Proclinical is currently recruiting for a Data Team Lead with a leading clinical research company located remotely. As the Data Team Lead, you will manage end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction.

Job Responsibilities:

  • Participate in and support RFP process (review RFP documents, pricing, attend bid defense)
  • Independently bring solutions to the CDM team/CDM department
  • Lead and/or participate in a focus team or global or local best practice team
  • Perform other duties as directed by the functional manager
  • Serve as primary point of contact for customer on data management deliverables
  • Provide project management expertise 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
  • Maintain the Data Management study files in the audit ready condition
  • Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables
  • Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders
  • Support DM service delivery with comprehensive DM process and technical expertise in executing projects
  • Serve as the escalation point for unresolved data issues; work with client data managers, vendors, internal team members for resolution
  • Work with functional manager(s) to ensure appropriate resources are assigned to meet project deliverables
  • Continuously look for opportunities to improve service; work with team to develop and implement plan to re-organise and drive change across multiple projects/programme (with minimal support)
  • Ensure timely follow-up and resolution of compliance issues
  • Serve as Subject Matter Expert (SME)
  • Provide leadership and expertise in a specific CDM task or technology
  • Train and mentor junior DTL staff in DM expertise. May coordinate the work of more junior DTL staff
  • Maintain internal tracking databases and systems
  • Ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW)
  • Lead and/or participate in a focus team or global or local standard methodology team
  • Communicate lessons learned and/or present in CDM workshop(s)
  • Participate in the development and implementation of new technology or tool
  • Present at professional conferences and/or publish articles in professional journals
  • Perform other duties as directed by the functional manager

Skills and Requirements:

  • Bachelor's Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related discipline, and 8 years direct Data Management experience, including 3 to 5 or more years as a CDM project lead; or equivalent combination of education, training and experience
  • Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology
  • Knowledge of operating procedures and work instructions and the ability to apply them in practice
  • Knowledge of GCP and relevant regulatory guidelines
  • Comprehensive understanding of clinical drug development process
  • Demonstrated extensive data management skills and thorough knowledge of the data management process (e.g., therapeutic area, deep understanding in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology)
  • Previous experience and shown competence in leading delivery of multiple projects through full DM life-cycle (several studies/programmes)
  • Previous experience of handling customer negotiations
  • Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology
  • Excellent organizational and analytical skills
  • Comprehensive understanding of clinical drug development process
  • Occasional travel is required

If you are having difficulty in applying or if you have any questions, please contact Divya Mistry at d.mistry@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-116607086_DM1

close