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Job #02592

About our client Our client is a provider of award-winning technology and global services. The company is an expert in integrated data collection and data management solutions. It caters to clinical trials and drug safety, helping them to automate and integrate management of the entire process, including study initiation, submitting to FDA as well as post-marketing studies. The company’s products have been involved in more than 10,000 and 1,000,000 clinical trials and study participants respectively in more than 250 of the best life sciences companies. Position Location Clinical Design Consultant (Clinical Data Manager) Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Deliver quality eClinical trial design, development, project management and consulting to pharmaceutical, biotechnology, medical device, CRO, and academic/public health clients 2) Oversee a variety of clinical trial functions, including eCRF design and development, preparation of edit checks and validation plan, development of trial extract specifications, reports, laboratory uploads, and Clintrial design and development 3) Advise customers to ensure that the trial design is configured in such a way that it meets the customer's goals and offers the full benefits of EDC (Electronic Data Capture) 4) Understand and follow all SOPs and work instructions 5) Apply clinical and data management principles, concepts and techniques 6) Work as a high-profile member of the project team to ensure excellent customer relationships are established throughout the development/implementation of the trial 7) Gather and interpret customer requirements and use trial design software, translate these into design specifications 8) Generate data export specifications to map data to customer requirements 9) Function as the design expert to advise internal and external customers regarding best practice for trial design 10) Work with the Study Team and Sales to scope required effort and define timelines 11) Provide advice and implement study design related changes throughout the trial life-cycle 12) Contribute to the continuing development of the product function and improvement of the clinical design working practices 13) Provide some mentoring to junior staff and client users Requirements 1) BA/BS degree or equivalent/Master’s degree in Public Health/Clinical Investigation a plus 2) Experience in the life science field working with clinical trials and/or has clinical data management experience 3) Experience designing protocol regulations 4) Experience in requirements gathering, design and specification development of CRFs, edit checks and site queries 5) Knowledge and understanding of regulations associated with clinical trial data handling, including 21 CFR Part 11 6) Knowledge of clinical trial data management as well as database structure and design 7) Demonstrated success with customers during project assessment, planning, development, training and implementation 8) Logical approach to problem-solving and excellent eye for detail 9) Ability to review and interpret clinical trial documentation (e.g. protocols) 10) Ability to work effectively in a fast-paced team or independent environment 11) Ability to manage multiple tasks and project deliverables 12) Excellent presentation, communication and negotiation skills 13) Willingness to travel – 20 – 25%