Manager, Clinical Data Management

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Alimentiv

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2020

⚕️ Healthcare Insurance

🔬 Science

💊 Pharmaceuticals

Healthcare Insurance • Science • Pharmaceuticals

Alimentiv is a specialty contract research organization focused on gastrointestinal (GI) and liver diseases. With over 30 years of experience, Alimentiv offers a comprehensive range of clinical research and imaging services, including clinical trial management, site management, regulatory affairs, and precision medicine. The company is at the forefront of medical research and development, providing state-of-the-art imaging solutions and actionable biomarker insights. Alimentiv supports the development of GI compounds and is active in more than 60 countries, working with a network of medical and operational experts to accelerate clinical trials and patient recruitment.

📋 Description

• Ensure operational efficiency and excellence by leading and/or assisting in the creation and documentation of new or revised department procedures. • Recommend appropriate departmental objectives that support the company strategy and objectives and create solutions to address business and operational challenges. • Lead working groups and/or committees to set goals and execute on implementation to address process or procedural gaps. • Partner with internal and external stakeholders to optimize Data Management technology, processes, and standards. • Participate in project and department budget development and responsible for effective management of budgets for assigned projects and staff. • Participate in the evaluation and selection of data system vendors to enhance Data Management processes, e.g. EDC, IRT, ePRO, eConsent. • Contribute to the financial success of the department and company by effectively managing financial aspects of assigned programs, including but not limited to Work Orders, Change Orders, study forecasting and budgeting. • Identify and quantify resource requirements for ongoing and future projects; Interview, hire, onboard and train new staff as appropriate. • Supervise, mentor, provide leadership and maintain positive team morale; facilitates conflict resolution. • Oversee development of direct reports by setting and tracking individual objectives and key results to support department and company strategies and objectives. • Evaluate training needs and conduct performance reviews for assigned staff. • Set priorities and oversee activities for assigned staff. • Ensure Data Management deliverables for projects assigned meet/exceed project/study team expectations regarding quality, time, and cost. • Serve as the subject matter expert on data collection strategy and handling of study data for assigned programs and effectively liaise with programming to ensure clinical databases are designed in a standard, accurate, complete, and consistent format to produce datasets that are conducive to analysis and a possible regulatory submission. • Proactively identify data management project issues, manage risks, and alert Senior Department Management with a view to remedial action. • Interact/liaise with other departments to ensure a high level of client satisfaction through successful issue resolution and execution of projects. • May work with other departments and analysts on special projects to ensure company end to end processes and technologies are efficient and effective, work seamlessly together and deliver improved customer value. • May represent Data Management at business development, sponsor, or other professional meetings. • Assist the business development team with RFIs, RFPs and project pricing.

🎯 Requirements

• Applicants should have a minimum of a college diploma/degree and 7-9 years of relevant experience. CCDM certification is considered an asset.