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Prometrika
Cambridge, MA, United States
PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to
Job Source: PrometrikaThor Companies
boston, ma
Manager, Data Management RESPONSIBILITIES • Manage and supervise a team of Clinical Data Managers (CDMs) Oversee each project assigned to the team QC each deliverable prior to sending to internal or external clients Prepare and present individual performance reviews Provide mentorship to DM staff and suggest/implement solutions for complex issues A
Job Source: Thor CompaniesThor Companies
Boston, MA, United States
Manager, Data Management RESPONSIBILITIES • Manage and supervise a team of Clinical Data Managers (CDMs) Oversee each project assigned to the team QC each deliverable prior to sending to internal or external clients Prepare and present individual performance reviews Provide mentorship to DM staff and suggest/implement solutions for complex issues A
Job Source: Thor CompaniesDeciphera Pharmaceuticals, Inc
Waltham, MA, United States
Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. In addition to advan
Job Source: Deciphera Pharmaceuticals, IncBayside Solutions
boston, ma
Manager, Clinical Data Management Direct Hire Full-Time Role Salary Range: $154,000 - $175,000 per year Location: Boston, MA - Hybrid or Remote Duties and Responsibilities: Oversee a team of Clinical Data Managers. Manage each project assigned to the team. Perform quality control for each deliverable before sending to internal or external clients
Job Source: Bayside SolutionsAditum Bio
Boston, MA, United States
Aditum Bio is a new model of biotech venture capital uniquely positioned to rapidly translate scientific discoveries into innovative new medicines. Aditum brings together unmatched scientific and domain expertise, combined with operational capabilities. Our agile operating model enables rapid company formation, planning, and execution for a new mod
Job Source: Aditum BioCRISPR Therapeutics
Boston
Job Description Job Description Company Overview Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, rege
Job Source: CRISPR TherapeuticsDeciphera Pharmaceuticals
Waltham, MA, United States
Job Description We are seeking a Manager to Lead Clinical Data Management (CDM) activities for clinical studies or a clinical program. This position will report to the Associate Director/Director of CDM and work on-site at our Waltham, MA office. Deciphera embraces a flexible workplace. You will work out of our Waltham, Massachusetts office. Decip
Job Source: Deciphera PharmaceuticalsCambridge
Job Description Job Description PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes.
RESPONSIBILITIES
Manage and supervise a team of Clinical Data Managers (CDMs) Oversee each project assigned to the team
QC each deliverable prior to sending to internal or external clients
Prepare and present individual performance reviews
Provide mentorship to DM staff and suggest/implement solutions for complex issues
Assist staff with interactions with sponsors and managing vendors
Keep supervisor updated on study progress and staff management through routine meetings
Maintain a positive, progressive, and proactive management style and communication
Develop and update data management SOPs and training manuals
Conduct data management training as well as study specific training for the CDM and study teams
Provide input from the data management perspective regarding the design of clinical trial protocols
Oversee, develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures
Oversee and participate in the process of data review and query generation procedures
Oversee and participate in the coding of medical terms
Oversee/define/perform SAE reconciliation processes
Work with DM leads and DB programmers to design (e)CRFs and edit checks in EDC system
Ensure proper completion of UAT of EDC system and modules
Oversee DM lead to ensure efficiency and quality of electronic data receipt, integration, and reconciliation
Review queries and trends to ensure data completeness and integrity
Review/prepare training materials and user guides for EDC data collection tools, deliver user training
Participate in client and team meetings as required advising on best practices as appropriate
Provide input to cross-functional study timelines and resource requirements to ensure timely completion of project milestones for complex studies
Provide regular status updates, keeping cross-functional study team, management, and sponsors informed of any changes
Implement technical solutions, new tools, and process improvement strategies
Lead large and complex projects
Identification of project scope changes
Present at sales and marketing meetings for prospective clients
Provide strategic input to the department and company goals
Lead key departmental goals and initiative
EDUCATION
Minimum BS in a scientific or health related field or equivalent
EXPERIENCE
Minimum of 10 years of experience in Clinical Data Management
Minimum 2 years supervisory experience is required
SKILLS
Knowledge of GCPs and regulatory agency guidelines
Familiarity with medical terminology is required
Skilled in the use of data management software application, Medidata RAVE
Excellent organizational and time management skills
Strong collaboration and leadership skills
Excellent oral and written communication skills
Strong interpersonal skills
Physical Requirements
Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time.
MANAGER DATA MANAGEMENT jobs in Cambridge
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