Clinical Data Manager / Senior Clinical Data Administrator

Clinical Data Manager /Senior Clinical Data Administrator * REMOTE, USA * Full-time permanent position * A competitive annual salary, health and medical insurance, vacation, IRA retirement plan, DPSP. Are you passionate about data management? Do you thrive in a dynamic clinical research environment, and are eager to work with a talented team? Are you excited about working on cutting-edge technology? If you’re up for a new and exciting challenge, with a company that offers a chance to have fun while you work, look no further. We’re Raise (https://raiserecruiting.com/) , and we’ve joined forces with our client, a full-service clinical research organization. For over 30 years they are providing successful clinical trials for the medical device, biotechnology and pharmaceutical industries.   What you’ll be doing As a Clinical Data Manager, you’ll be reporting to the Director of Clinical Services and Data Management and playing an important role in the overall company operation. This position is responsible for study data management and working effectively with clinicians, allied healthcare personnel, clients, vendors, and internal staff. The best in this role are people who can wear multiple hats and who have a blend of both strong database and data management skills and who have a growth mindset. To be successful in this role, you must be self-motivated, well-organized, proactive, collaborative, and adaptable. Practically speaking, you will: * Interface with clinical Project Manager(s) and statistician(s) to establish project data management plans and requirements, and database implementation schedules and other key study documents * Interface with IT Manager, Project Manager, and Software Developer to review project database implementation schedules, database utilization training, and database utilization efficiency * Participate in the department project Clinical Data system design, utilization, and maintenance to maintain conformance with FDA guidelines for Clinical Data management * Review protocols for CRF design and creation and develop electronic CRFs for use in Clinical Data management systems * Develop and maintain data management documentation including: Data Management Plan, Database Development Specifications with Edit Check Specifications, Data Review Guidelines, and other Data Management Specific documents * Create and develop database specification documentation for database programming according to CRF  * Collaborate with biostatisticians in the creation of analysis datasets * Program and develop database in accordance with database specification and CRF documentation * Modify database to accommodate any requested database updates or modifications * Program and generate reports within database as requested by sponsor and/or project team * Create test data and perform user acceptance testing on new databases * Complete ongoing data review activities for assigned study and provided feedback to study teams * Coordinate with Coder or complete coding activities throughout the study * Coordinate with external vendors as needed for assigned study * Perform database quality assurance audits and database locks * Establish and maintain department Standard Operating Procedures for data management activities.  Work with Quality Systems Manager and/or Administrator to revise, develop, or implement new procedures as required * Provide recommendations for improvement of project or divisional efficiencies based on work experience and observations * Participate in project review meetings as requested * Participate in business development proposal team and presentations as needed * Participate in budget maintenance for project data management-related activities The Details This is a full-time permanent REMOTE position based in any locations across USA. The head office is in Costa Mesa, CA USA. There will be light travel required for this role, to attend client/vendor meetings and customers. In addition to a competitive base salary in the range of $90,000 -$150,000 (commensurate with experience), you’ll enjoy a robust benefits package and vacation. Skills and Qualifications * BS or BA degree * 5+ years experience in data management * Ophthalmology experience * Proficiency in Data Management Plan development and maintenance * ePRO experience * Proficiency in EDC systems (including Medrio and Medidata Rave) with database development, query management, reports generation and associated database specification documentation * Database build experience, including experience with programming and database set up within Medrio and other EDC systems  * Experience with study start up tasks, CRF design, database development, edit check creation, eCRF completion guidelines, validation and user acceptance testing * Thorough understanding of FDA, ICH and GCP regulations and guidelines regarding management of data for clinical studies * Familiarity with current data standards (e.g., XML/CDISC) and database administration * Knowledge of programming in SQL reporting using Microsoft SQL Reporting Services and Crystal Reports desirable * Understanding of coding process and dictionaries * SAE Reconciliation and external data reconciliation experience * Strong communication skills as demonstrated via telephone interactions, personal presentations, and general written correspondence. * Well-organized, with strong attention to detail, documentation, and follow-through.  Ability to work on multiple tasks simultaneously. * Leadership skills, and ability to work effectively within a team configuration  * Willingness to both lead studies as Data Manager and complete ongoing data management review from start up through database lock for assigned studies  * Pharma and medical device experience preferred.   Your Application We value diversity and inclusion and encourage all qualified people to apply; however, only those selected for an interview will be contacted. Looking for meaningful work? We can help Raise is an established hiring firm with over 60 years of experience. We strive to build teams that reflect the diversity of the communities we work in and encourage applications from traditionally underrepresented groups such as women, visible minorities, Indigenous peoples, people identifying as LGBTQ2SI, veterans, and people with visible/nonvisible disabilities.  We have a dedicated webpage for accommodations where you can learn more about what we offer, and request accommodation: https://raise.jobs/accommodations/ While recruiters require certain personal information to submit candidates for job opportunities, Raise will never ask you for personal or banking information as part of the application—we will only collect personal information once you’ve been selected for a job. If you are ever unsure about the legitimacy of this or another job posting by Raise (or have any other questions), please contact us at +1 800-567-9675