Proclinical is currently recruiting for a Senior Clinical Data Manager with a Clinical Research Organization located in New York, North Carolina, Texas and California. Successful candidate will independently 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:
- Serve as primary point of contact for customer on data management deliverables; manage multiple large studies or program of studies (possibly global).
- Provide leadership and senior support to DTLs on multiple large global studies/program of global studies.
- 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.
- 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.
- 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.
- Independently manage SOW/budget.
- Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing.
- Independently support RFP process (review RFP documents, pricing, attend bid defense).
- Independently bring process improvements and solutions to the CDM team/CDM department.
- Lead a focus team or global or local best practice team.
- Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions.
- Perform other duties as directed by the functional manager.
Skills and Requirements:
- BS or educational equivalent, in health, clinical, biological or mathematical sciences, or related field, and 7+ years direct Data Management experience, including 5+ 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.
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 Susan Chapman at (+1) 646-542-0158
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.
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