Lead Clinical Data Manager

Join to apply for the Lead Clinical Data Manager role at HiPaaS Inc. 1 day ago Be among the first 25 applicants Join to apply for the Lead Clinical Data Manager role at HiPaaS Inc. Get AI-powered advice on this job and more exclusive features. This range is provided by HiPaaS Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range HiPaaS empowers healthcare organizations, startups, and enterprises to implement AI solutions that transform operations, enhance care, and drive growth.The RoleClinical Data ManagerJob DescriptionThe Lead Clinical Data Manager (LCDM) oversees all project management documentation and clinical data management activities, ensuring the quality and integrity of the final locked clinical database. The LCDM manages all clinical data management operations, including database audits, coding, SAE reconciliation, system and module testing, data cleaning, and database locking/unlocking.The LCDM ensures other Data Managers are trained and supervises the quality of database setup, including essential documents and activities. They manage outsourcing vendors and approve key study documents, such as CCGs, Raw Data Validation Checks, User Acceptance Testing documents, eCRF development, and database lock plans.The LCDM must thoroughly understand Good Clinical Data Management requirements and documentation, actively participate in the startup and closeout of in-house and client-specific data management projects, and possess strong knowledge of therapeutic indications, study hypotheses, trial design, database design, and structure.Essential FunctionsMain point of contact for all the data management deliverables for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Lead data management projects, oversee study progress, quality of work, quality check processes and essential documents. Communicate with sponsors, sites, and other departments to facilitate data collection and resolve issues. Communicate lessons learned and/or present in CDM workshop(s) Lead DM kick off meetings and point of DM contact in cross functional team meetings. Manage SOW and track the project status and finance health monthly and participate in project reviews as requested - identify out of scope tasks and track change orders to completion. Main point of contact for financial tracking, revenue recognition, and invoicing. Oversee the monthly study hours and communicate with the finance team for invoicing. Should be able to take up project manager role and coordinate with multiple teams like DM, SAS and Biostats team. Create project timelines aligning with cross functional team activities. Assist in tracking and managing projects, identifying risks, and taking corrective actions. May provide training in basic data management expertise to new team members. Assist Manager, CDM and VP in process improvements and automations. Train junior Clinical Data Managers, guide and help them through data management activities. Ideal ProfileQualifications For Essential FunctionsAbility to communicate effectively in the English language in person, by phone and in writing. Ability to lead functional meetings. Strong attention to detail and accuracy is a must. Excellent organizational skills. Demonstrated ability to manage multiple projects. Ability to work collaboratively, effectively, and productively in diverse organization structures. Ability to work independently, take initiative and complete tasks to deadlines: Delivering Excellence, Serving Customers, Accountability and Ownership, Global and Cross-Functional Communication. Ability to work in a team-oriented, collaborative environment. Ability to work positively within a continually changing environment. Ability to effectively prioritize and execute tasks in a high-pressure environment. Advanced computer skills and practical knowledge of MS Office and potentially project management software. Education And Experience RequiredA bachelor’s degree in life science is required. 7-10 years of core clinical data management experience is required, 2+ years of study lead experience is required. Prior experience in leading the studies is required. Prior experience in leading Study start up and close out activities is required. Experience working on different EDC systems (Medidata Rave, Veeva EDC, Oracle EDC, Medrio etc is required. Experience in multiple vendor reconciliations (Lab, ECG, PK etc) is required. Prior Integrations (IRT, Lab and ECG integrations etc) experience is required. Able to work in shifts. 9-6 PM for Local clients and 2-11 PM for US clients. Working knowledge of EDC studies is required and SAS is preferred. Work RequirementsCorporate office environment or remote. Cross-functional interactions TRAININGComplete Training Requirements per current Training Requirements List. Supervisor may assign additional skills training, one-on-one, see-one / do one, or other Training as necessary to achieve qualifications and improve job performance. What's on Offer?Work alongside & learn from best in class talent Join a well known brand within Hospital / Health Care / Healthtech Leadership Role Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Research, Analyst, and Information Technology Industries Hospitals and Health Care Referrals increase your chances of interviewing at HiPaaS Inc. by 2x Get notified about new Clinical Data Manager jobs in Philippines . We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr