Clinical Data Lead (home-based)

Hobson Prior currently have an excellent opportunity for a Clinical Data Lead to join a leading CRO who are focused on providing solutions to drive healthcare forward. This position is on a permanent basis where you will be required to work remotely.

Please note that to be considered for this role you must have the right to work in this location.

Job Responsibilities:

Client Management:

• To act as the primary point of contact for customer on data management deliverables.
• Ensure open communications with customer and Quintiles management to manage and meet contractual obligations.
• To 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.
• Provide justification for and perform direct negotiations with customer, e.g., timelines, financial, process, resources.

Financial Management/Business Development Support:

• Ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work.
• Manage SOW/budget.
• Review financial reports on a monthly basis and participate in project reviews as requested.
• Recognise out of scope tasks and track change orders to completion.
• Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing.
• Partake in and support RFP process (review RFP documents, pricing, attend bid defense).

Service Management:

• Meet with Data Operations Coordinator 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 managers to ensure appropriate resources are assigned to meet project deliverables.
• Create and/or review and sign-off on all data management plan documents.
• Ensure service and quality meet agreed upon specifications per the DMP and contract/SOW.
• Implement proactive quality management plans across multiple projects/programmes.

Any other assigned duties.

Key Skills:

• Excellent project management skills.
• Excellent organizational and problem-solving skills.
• Ability to work self-sufficiently with available resources, e.g., functional managers, senior DTLs.
• Demonstrated expert data management skills and thorough knowledge of the data management process.
• 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 Good Clinical Practices and relevant regulatory guidelines.
• Comprehensive understanding of clinical drug development process.

Requirements:

• Bachelor's Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field.
• At least 5+ years direct Data experience, including 1 or more years as a CDM project lead; or equivalent combination of education, training and experience.
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
• Previous experience and proven competence in managing delivery of multiple projects through full DM life cycle (several studies/programmes).
• Extensive use of keyboard requiring repetitive motion of fingers.
• Regular sitting for extended periods of time.
• Prior experience of handling customer negotiations.
• Occasional travel is required.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.