Manager Clinical Data Management

3 weeks ago

Cambridge, United States ClinLab Staffing Full time

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

    21 hours ago

    Cambridge, United States ClinLab Staffing Full time

    MANAGER 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...

  • Manager Clinical Data Management

    3 weeks ago

    Cambridge, United States ClinLab Staffing Full time

    MANAGER 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

    4 weeks ago

    Cambridge, United States AL Solutions Full time

    Job 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

    3 weeks ago

    Cambridge, United States AL Solutions Full time

    Job 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...

  • Senior Clinical Data Manager

    3 weeks ago

    Cambridge, Massachusetts, United States AL Solutions Full time

    Ashley 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 this role, you will play a...

  • Senior Clinical Data Manager

    3 weeks ago

    Cambridge, Massachusetts, United States AL Solutions Full time

    George 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 oversight of data management...

  • Senior Director, Clinical Data Management

    3 weeks ago

    Cambridge, United States Editas Medicine Full time

    Job 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....

  • Senior Director, Clinical Data Management

    3 weeks ago

    Cambridge, Massachusetts, United States Editas Medicine Full time

    At 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. We believe our people are at...

  • Associate Director, Clinical Operations

    2 weeks ago

    Cambridge, United States Clinical Dynamix, Inc. Full time

    Role: 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 Project Manager

    3 days ago

    Cambridge, United States Relay Therapeutics Full time

    The 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...

  • Clinical Program Manager

    3 weeks ago

    Cambridge, United States CareerBuilder Full time

    Description We're looking for a Clinical Program Manager , working in Pharmaceuticals and Medical Products industry in 40 Landsdowne Street, Cambridge, Massachusetts, 02139, United States . Job description: Manage Therapeutic Area Programs of a highly complex nature and/or high risk programs including, multiple indications, data safety monitoring boards,...

  • Senior Clinical Trial Manager

    2 weeks ago

    Cambridge, United States Boston Pharmaceuticals Full time

    Company Overview Boston Pharmaceuticals is a clinical-stage biopharmaceutical company. We are developing highly engineered targeted therapies for patients with serious liver diseases. Our lead investigational program, BOS-580, is a long-acting once-monthly FGF21 analogue being studied in a Phase 2 clinical trial for metabolic dysfunction-associated...

  • Senior Clinical Trial Manager

    2 weeks ago

    Cambridge, United States Boston Pharmaceuticals Full time

    Company OverviewBoston Pharmaceuticals is a clinical-stage biopharmaceutical company. We are developing highly engineered targeted therapies for patients with serious liver diseases. Our lead investigational program, BOS-580, is a long-acting once-monthly FGF21 analogue being studied in a Phase 2 clinical trial for metabolic dysfunction-associated...

  • Senior Director of Data Management

    3 weeks ago

    Cambridge, United States EPM Scientific Full time

    Senior Director of Data Management and ReportingCambridge, MA (hybrid) I am partnered with a large pharmaceutical company looking for an experienced commercial data management professional to serve as the Data Steward and to develop and lead data strategy and governance processes. Key Responsibilities:Direct the Data Strategy and Management team to develop...

  • Senior Director of Data Management

    4 weeks ago

    Cambridge, United States EPM Scientific Full time

    Senior Director of Data Management and ReportingCambridge, MA (hybrid) I am partnered with a large pharmaceutical company looking for an experienced commercial data management professional to serve as the Data Steward and to develop and lead data strategy and governance processes. Key Responsibilities:Direct the Data Strategy and Management team to develop...

  • Manager/Sr. Manager, Clinical Supply Chain

    5 days ago

    Cambridge, United States Cullinan Therapeutics Full time

    Summary: Cullinan Oncology is seeking an experienced Sr. Manager reporting to the Senior Director of Supply Chain, you will support the planning, creation, implementation, build, and optimization of the clinical supply chain to ensure uninterrupted and timely clinical drug supply for Cullinan's clinical programs. Position Responsibilities: Support the...

  • Program Coordinator

    1 week ago

    Cambridge, United States Maxis Clinical Sciences Full time

    Job DescriptionJob DescriptionDescription:ACTUAL TITLE: IT Operations CoordinatorClient's Global R&D Discovery IT team is offering a tremendous opportunity for an experienced IT Operations Coordinator to play a vital role in the delivery of technology solutions of value to meet the expanding needs of Client's global IT mission. Come join a growing...

  • IT Operations Coordinator

    1 week ago

    Cambridge, United States Maxis Clinical Sciences Full time

    Job DescriptionJob DescriptionClient's Global R&D Discovery IT team is offering a tremendous opportunity for an experienced IT Operations Coordinator to play a vital role in the delivery of technology solutions of value to meet the expanding needs of Client's global IT mission. Come join a growing team and we strive to advance solution delivery to a...

  • 2024 Summer Data Manager

    2 weeks ago

    Cambridge, United States Cambridge Public Schools Full time

    Description of Service Opportunity: The 2024 Summer Data Manager will manage student data and registration information for all CPS Summer Academic programs for students currently in grades K-7. This position is hired by the office of the Chief Operating Officer and reports to the Operations Manager. The Summer Data Manager is responsible for compiling and...

  • Senior Manager, Clinical Supply Chain

    4 weeks ago

    Cambridge, United States Agios Pharmaceuticals Full time

    Senior Manager, Clinical Supply Chain  Who we are: is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with...