Data Manager - Team Lead
Proclinical is currently recruiting for a Data Manager for a CRO located remotely. Successful candidate will serve as the primary point of contact for customer on data management deliverables and manage multiple large studies or program of studies.
- Provide leadership and senior support to DTLs on multiple large global studies/programme of global studies
- 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
- Lead direct negotiations with customer, e.g., timelines, financial, process, resources ? Maintain strong customer relationships
- Ensure open communications with customer and Quintiles management to independently manage and meet contractual obligations
- Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables; provide training and development on data management expertise to junior team members
- Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders
- Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects
- Serve as the escalation point for unresolved data issues; independently work with client data managers, vendors, internal team members for resolution
- Ensure appropriate resources are assigned to meet project deliverables
- Create and/or review and sign-off on all data management plan (DMP) documents;
- Ensure service and quality meet agreed upon specifications per the DMP and contract/SOW
- Implement proactive quality management plans across multiple projects/programmes/customer account. Manage service performance and provide leadership to identify root causes of issues and implement remedial actions
- Continuously look for opportunities to improve service; develop and work with team to implement plan to re-organise and drive change (possibly across a customer account)
- 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
- Serve as customer site lead for one or more customers
- Train and mentor junior DTL staff in DM expertise; may coordinate the work of more junior DTL staff
- Independently maintain internal tracking databases and systems
Skills and Requirements:
- Bachelor's Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field.
- 7+ years direct Data Management experience, with 5 or more years as a CDM project lead; or equivalent combination of education, training and experience
- Previous experience and proven competence in managing delivery of multiple global trials through full DM life-cycle (i.e. large trials of at least 1000 patients)
- Demonstrated expert data management skills and advanced knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology)
- Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently
- 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
- Excellent communication, interpersonal, customer service, and teamwork skills
- Excellent organizational and problem-solving skills
- Excellent project management skills
- Ability to work independently
- Comprehensive understanding of clinical drug development process
- Ability to establish and maintain effective working relationships with coworkers, managers and customers
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 Felix Hook at (+1) 646-367-2617 or upload your resume 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.
Proclinical Staffing is an equal opportunity employer.