Manager Clinical Data Management
2 weeks ago
MANAGER DATA MANAGEMENT
Cambridge, MA, US
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 8-10 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
-
Manager Clinical Data Management
1 month ago
Cambridge, United States ClinLab Staffing Full timeMANAGER DATA MANAGEMENTCambridge, MA, USRESPONSIBILITIESManage and supervise a team of Clinical Data Managers (CDMs)Oversee each project assigned to the teamQC each deliverable prior to sending to internal or external clientsPrepare and present individual performance reviewsProvide mentorship to DM staff and suggest/implement solutions for complex...
-
Senior Clinical Data Manager
2 months ago
Cambridge, United States AL Solutions Full timeJob DescriptionJob DescriptionAshley Smith-Brown is partnered with a rapidly growing International Life Science partner who are looking for an experienced Senior Clinical Data Manger to join their expanding Biometrics team.Position Overview:Ashley Smith-Brown is seeking an experienced and motivated Senior Clinical Data Manager to join their growing team. In...
-
Senior Clinical Data Manager
1 month ago
Cambridge, United States AL Solutions Full timeJob DescriptionJob DescriptionGeorge Higginson is currently searching for a highly experienced Senior Clinical Data Manager for the up-and-coming CRO, specialising in Oncology. The Senior Clinical Data Manager is responsible for the oversight and management of data management activities to ensure high quality data collection tools, database design and...
-
Director, Clinical Data Management
2 weeks ago
Cambridge, United States Sana Biotechnology Full timeAbout the role Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As a Director Clinical Data Management, this individual will report to the Senior Director Clinical Data Management to be...
-
Director, Clinical Data Management
2 weeks ago
Cambridge, Massachusetts, United States Sana Biotechnology Full timeAbout the roleSana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As a Director Clinical Data Management, this individual will report to the Senior Director Clinical Data Management to be...
-
Director, Clinical Data Management
1 week ago
Cambridge, United States BioSpace Full timeJob DetailsAbout the role Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As a Director Clinical Data Management, this individual will report to the Senior Director Clinical Data Management to...
-
Senior Clinical Data Manager
4 days ago
Cambridge, United States PROMETRIKA, LLC. Full timePROMETRIKA 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....
-
Senior Clinical Data Manager
5 days ago
Cambridge, United States PROMETRIKA, LLC Full timePROMETRIKA 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...
-
Senior Clinical Data Manager
3 days ago
Cambridge, United States Prometrika LLC Full timeJob DescriptionJob DescriptionPROMETRIKA 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...
-
Cambridge, Massachusetts, United States Philips Full timeJob TitleClinical Operations Manager – Clinical Data Intelligence (Cambridge, MA)Job DescriptionClinical Operations Manager – Clinical Data IntelligenceYou will be responsible for Clinical Operations Management for research partnerships related to the Philips BReakthrough Innovation TEams (BRITE) Clinical Data Intelligence Team, working closely with...
-
Senior Director, Clinical Data Management
1 month ago
Cambridge, United States Editas Medicine Full timeJob DescriptionJob DescriptionAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing....
-
Cambridge, Massachusetts, United States Philips Full timeJob TitleClinical Operations Manager – Clinical Data Intelligence (Cambridge, MA)Job DescriptionClinical Operations Manager – Clinical Data IntelligenceYou will be responsible for Clinical Operations Management for research partnerships related to the Philips BReakthrough Innovation TEams (BRITE) Clinical Data Intelligence Team, working closely with...
-
Manager/Sr Manager, Data Management
2 days ago
Cambridge, United States Innova Solutions Full timeInnova Solutions Client is immediately hiring for a Manager/Sr Manager, Data Management Position type: Full Time Perm Location: Preferred location Cambridge, MA / Remote Salary: $175K - $185K depending on experience and level, might go up on the salary for the right candidate As a Manager/Sr Manager, Data Management you will: RESPONSIBILITIES Manage and...
-
Cambridge, United States Clinical Dynamix, Inc. Full timeGlobal Biotech company with US Headquarters outside Boston, MA is expanding. Looking for Dynamic Leader to work remotely (possible meetings and functions each quarter in Waltham, MA office)The AD, Monitoring Oversight is responsible for Oversight and implementing a global sponsor oversight monitoring program within the clinical operations department. This...
-
Associate Director, Clinical Data Management
4 days ago
Cambridge, United States Actalent Full timeDescription:Develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, add Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures· Work with DB programmers to design (e)CRFs...
-
Clinical Project Manager
3 weeks ago
Cambridge, United States Relay Therapeutics Full timeThe Opportunity: As Clinical Project Manager, you will be accountable for managing clinical studies that will lead the biopharma industry in speed and quality of clinical study design and execution. You will be an integrated member of the Relay Tx scientific team, responsible for the execution of clinical studies that will translate Relay's innovative...
-
Associate Director, Clinical Operations
4 weeks ago
Cambridge, United States Clinical Dynamix, Inc. Full timeRole: Associate Director, Clinical Operations We are looking for a energetic and passionate Associate Director, Clinical Operations who is excited to plan and lead timely and high quality oncology clinical trial execution. The ideal candidate has a track record of executing complex, on-time clinical trials at a biotech/pharma company and has begun working...
-
Clinical Trial Manager
4 days ago
Cambridge, United States Alnylam Pharmaceuticals, Inc. Full timeOverview The Clinical Trial Manager is responsible for aspects of clinical development planning and strategy, clinical study planning and execution within pre-specified clinical development program, timelines and budget and includes, but is not limited to, preparation of study related materials, relationship management between study sites and vendors (in...
-
Clinical Trial Manager
5 days ago
Cambridge, United States Alnylam Full timeOverview The Clinical Trial Manager is responsible for aspects of clinical development planning and strategy, clinical study planning and execution within pre-specified clinical development program, timelines and budget and includes, but is not limited to, preparation of study related materials, relationship management between study sites and vendors (in...
-
Sr. Manager, Clinical Science
5 days ago
Cambridge, United States ONO PHARMA USA Full timeResponsibilities:Utilizing company’s clinical development strategy, while complying with pharmaceutical industry practices and regulatory guidelines, serves as a Sr. Manager of Clinical Science (Clinical Science Lead, Immunology) on the Clinical Research and Development team, responsible for leading or supporting the design, data collection and clinical...