| Looking for : Lead Clinical Data Manager : no H1B CPT at Remote, Remote, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=273342&uid= From: Aakanksha Singh, RCI [email protected] Reply to: [email protected] Role: Lead Clinical Data Manager Location: Remote (PST Hour) Duration: 6-12 Month OVERALL RESPONSIBILITIES: The Lead Clinical Data Manager will be responsible with leading all aspects of clinical data management associated with data cleaning and quality review processes for assigned projects. S/he ensures clinical trial data collected meet the highest standards of data integrity, while meeting timelines and budgets. POSITION DUTIES & RESPONSIBILITIES: Reporting to the Manager, Data Management this individual will; Mentor, train and supervise junior associates as needed in clinical data management processes and procedures; Independently lead several complex trials; Lead CRF design, review and validation of clinical database, including management of CRO activities in this area as assigned if required; Be responsible for creation of data management plans and other data management documentation as needed; Monitor progress and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target to project timelines partnering as appropriate with Clinical Operations, Franchise and other BSDM functions; Lead, coordinate, facilitate and manage all data management activities from initiation of protocol through database lock, partnering as appropriate with Clinical Operations, Franchise and other BSDM functions for their respective projects; Proactively organize and manages ongoing data review throughout study conduct, including being responsible for the correction of errors and discrepancies management for the life of a project; Proactively identify and address issues that may impact the quality of the data, deliverables or timelines; Be responsible for identification of data handling processes for non-CRF data, including lab data and image handling; Work with BSDM leadership, and leadership in Clinical Operations and Franchise to develop project management plans for trial execution including timelines milestones and budgets; Lead efforts co-ordinating with Medical Affairs organization to facilitate data coding and safety reviews as needed; Independently lead new data management initiatives and contribute towards process improvement, data standards and efficiency gaining initiatives within data management working with the project leader data standards to implement; Be responsible for ensuring all clinical data management documentation is stored and archived in a timely and compliant manner; Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times; Diligently participate in compliance program-related activities as denoted by the supervisor or Chief Compliance Officer; Perform other related duties as required. Functional and Technical Competencies: Therapeutic area knowledge in at least one of cardiovascular, Neurovascular, or general surgery. Proficient in computer technology used in an office environment (Microsoft Word, Excel, etc). Excellent verbal and written communication skills. Knowledge of GCP and regulatory requirements regarding clinical data management documentation and software. Experience with Electronic Data Capture (EDC), Medidata RAVE preferred. Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug). Leadership Competencies: Connect - Develop strategic partnerships with key internal stakeholders to ensure projects remain on target to project timelines. Shape Develop knowledge of therapeutic areas within the Franchises. Lead Lead data management representation on project teams to ensure deliverables are met. Lead Serve as a role model in data management practices and mentor junior data management staff. Deliver ensure projects are delivered on time, within budget and in compliance to regulations and SOPs. EDUCATION & EXPERIENCE REQUIREMENTS: A Bachelors degree (or equivalent) in the biological sciences, Computer Science or related discipline, with at least 6 years of clinical data management experience in Medical Device or Pharmaceuticals including experience of successful active participation in cross-functional teams. Keywords: Colorado http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=273342&uid= |
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| 11:25 PM 12-Jan-23 |