Clinical Data Manager / Project Data Manager - Sponsor-dedicated, Poland

Clinical Data Manager / Project Data Manager - Sponsor-dedicated, Poland Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.   Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.   Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.   Discover what your 25,000 future colleagues already know:   Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Title: Clinical Data Manager                                                                    Department:    Data Management (Biostatistics) FSP Model                                                                                                      Job Summary The Clinical Data Manager performs activities pertaining to the conduct of Phase I-III clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines. The CDM ensures, from a data management perspective, assigned trials on time, within budget, and with highest achievable quality. Summary of the Essential Functions of the Job Participate as the primary data management representative on Incyte multidisciplinary project teams and ensure effective communication exchange. Responsible for communicating key clinical data management metrics (e.g., data entry status, query resolution and aging, etc.) and determining appropriate actions in conjunction with study team. Responsible for the review, development and/or writing of clinical trial documents and manuals, including but not limited to Case Report Forms, Edit Checks, Data Management Plans, Clinical Data Review Plans and eCRF Completion Guidelines. Participate in User Acceptance Testing (UAT), as needed. Participate in Quality Control (QC), as needed. Responsible for working with the assigned Clinical Database Programmer(s) to ensure the development of the Data Flow Chart(s), Data Transfer Specifications and Import Guidelines. Assist with site and/or third party vendor training on CDM-related topics. Responsible for providing data review training and guidance to Sr. Clinical Data Coordinators that are supporting their trial(s). Perform data review and discrepancy resolution, as needed. Responsible for archiving trial(s) and associated documentation upon trial(s) completion. Ensure adherence to Good Clinical Practice and all applicable local and international regulations. Minimum