Talent.com
Katalyst HealthCares & Life Sciences
Sr. Clinical Data ManagerKatalyst HealthCares & Life Sciences • Boston, MA
Sr. Clinical Data Manager

Sr. Clinical Data Manager

Katalyst HealthCares & Life Sciences • Boston, MA
30+ days ago
Job type
  • Full-time
Job description

Responsibilities:
  • Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelines, etc.
  • Perform or provide oversight to staff for all CDM activities from study startup to archival: design CRFs/eCRFs, create Data Validation Specifications, Data Management Plans, eCRF Completion Guidelines, and Data Review Plans, code terms in MedDRA and WHO Drug; and complete data base lock, archival, and closeout activities
  • Develop and manage standard operation procedures (SOP and CLPs) for clinical investigation data management; Data Management Plans (DMP), eCRFs, user acceptance testing (UAT) plans and scripts; EDC build and associated edit checks
  • Provide study level metrics/reports and external data reconciliation processes relating to CRF review, query status, data entry, monitoring status, management of independent review vendors, and any other relevant matters; translate metrics into performance assessment and opportunities
  • Collaborate with cross-functional team and management to implement and govern CDM processes and standards to meet all applicable quality requirements and regulations, manage and oversee all phases of data management activities
  • Provide program/study level oversight and expertise for CDM activities for multiple studies
  • Review clinical data on an ongoing basis to ensure consistency, integrity and accuracy; assess and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns
  • Establish external data reconciliation processes; develop CDM processes for management and determination of adjudication for independent review of video-endoscopies, CT scans
  • Evaluate and manage CROs and external technology vendors to meet company's goals and CDM standards
  • Build and drive positive relationships and teamwork within the clinical team and partnering sites with professional demeanor
  • Make decisions and chart course through careful evaluation of risks and benefits with limited information in conjunction with leadership; serve as the interdepartmental subject matter expert for the CDM area
  • Evaluate and manage CROs and external technology vendors to meet company's goals and clinical data management quality standards on an ongoing basis
  • Assist with routine quality audits as applicable

Requirements:
  • Bachelor's Degree in scientific discipline (RN or advanced degree preferred)
  • years' industry experience in CDM in all study phases and activities from startup to archival with at least years in lead role for clinical development programs with medical devices leading toward FDA filing / approvals
  • Thorough knowledge of the CDM standards for medical devices (Class III PMA devices preferred)
  • Expertise in development, validation, and management of the clinical study database throughout its life cycle, from CRF design, database development and testing, discrepancy management, data quality review and database close and lock procedures, CDASH and SDTM data formats
  • Working knowledge of the GCP, ICH and FDA guidance and regulations for clinical trials
  • Working knowledge of the MedDRA and WHODrug dictionary coding terms Able to complete tasks independently, accurately and efficiently with attention to detail and in a timely manger
  • Experience in implementing, validating, and administrating other clinical systems for data collection (, eSource, IVRS, IWRS, core lab web-based portals)
  • Demonstrated ability to manage complex projects with tight timelines and overcome project roadblocks

Create a job alert for this search

Sr. Clinical Data Manager • Boston, MA

Similar jobs

Travel Nurse - RN - ICU - Intensive Care Unit - $2035 / Week

LRS Healthcare - NursingSalem, MA, US
Full-time

LRS Healthcare - Nursing is seeking an experienced Intensive Care Unit Registered Nurse for an exciting Travel Nursing job in Salem, MA.Shift: Inquire Start Date: 06/14/2026 Duration: 13 weeks Pay:... Show more

 • Promoted

Travel CT Tech - $2819.96 / Week

Premier Medical Staffing Services, LLCLawrence, MA, US
Full-time

Premier Medical Staffing Services, LLC is seeking an experienced CT Tech for an exciting Travel Allied job in Lawrence, MA.Shift: 5x8 hr flex Start Date: 06/22/2026 Duration: 13 weeks Pay: $2819.Ab... Show more

 • Promoted

Sr. Clinical Research Associate

GetingeBoston, MA, US
Temporary

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally.At Getinge we exist to make life-saving technology accessible for more people.... Show more

 • Promoted

Clinical Data Manager - Remote

Beacon Therapeutics (USA) IncCambridge, MA, United States
Remote
Full-time

Job DescriptionJob DescriptionJoin Beacon Therapeutics as a Full Time Clinical Data Manager and play a crucial role in transforming the landscape of biotech.This fully remote position allows you to... Show more

 • Promoted

Travel Nurse - RN - Infection Control - $2206 / Week

LancesoftLawrence, MA, US
Full-time

Lancesoft is seeking an experienced Infection Control Registered Nurse for an exciting Travel Nursing job in Lawrence, MA.Shift: 3x12 hr days Start Date: 12/02/2026 Duration: 13 weeks Pay: $2206 / ... Show more

 • Promoted

Senior Manager, Clinical Partner Outsourcing

Takeda PharmaceuticalBoston, MA, US
Full-time

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Tak... Show more

 • Promoted

Market Clinical Director

ChenMedSalem, IN, US
Full-time

We’re changing lives every day.For both our patients and our team members.Are you innovative and entrepreneurial minded? Is your work ethic and ambition off the charts?  Do you inspire others with ... Show more

 • Promoted

Travel Nurse RN - Case Manager - $1,120 per week in Lawrence, MA

TravelNurseSourceLawrence, MA, US
$1,120.00 weekly
Full-time

Registered Nurse (RN) | Case Manager.TravelNurseSource is working with Advantis Medical Staffing to find a qualified Case Manager RN in Lawrence, Massachusetts, 01840!.Advantis Medical, the #1 rate... Show more

 • Promoted

Travel Nurse - RN - Case Manager - $1087.5 / Week

Host HealthcareDanvers, MA, US
Full-time

Host Healthcare is seeking an experienced Case Manager Registered Nurse for an exciting Travel Nursing job in Danvers, MA.Shift: Inquire Start Date: 07/13/2026 Duration: 13 weeks Pay: $1087.At Host... Show more

 • Promoted

Travel Nurse - RN - Infection Control - $2206 / Week - Hiring Now

LancesoftLawrence, MA, US
Full-time

Lancesoft is seeking an experienced Infection Control Registered Nurse for an exciting Travel Nursing job in Lawrence, MA.Shift: 3x12 hr days Start Date: 12/02/2026 Duration: 13 weeks Pay: $2206 / ... Show more

 • Promoted

Chief of Cardiology

HealthEcareers - ClientBrockton, MA, USA
Full-time

This senior leadership role is responsible for strategic, clinical, and operational oversight of all cardiology services within.The Chief of Cardiology will report directly to the Chief of Medical ... Show more

 • Promoted

Clinic Manager RN

Crossover HealthBoston, MA, United States
Full-time

Crossover Health is seeking a Clinic Manager for our brand new second clinic coming to Boston ( Hours M-F 8am-5pm ) phlebotomy exp required ( September 2026 Start date).Seaport Blvd, Boston, MA 022... Show more

 • Promoted

RN Clinical Care Manager Roxbury/Dorchester, MA

CareSourceBoston, MA, US
Full-time

Commonwealth Care Alliance (CCA) is a nonprofit, mission-driven health plan and care delivery organization designed for individuals with the most significant needs.As an affiliate of CareSource, a ... Show more

 • Promoted

Sr. Manager, R&D

GetingeBoston, MA, US
Full-time

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally.At Getinge we exist to make life-saving technology accessible for more people.... Show more

 • Promoted

Clinical Operations Manager - Remote

Beacon Therapeutics (USA) IncCambridge, MA, United States
Remote
Full-time

Job DescriptionJob DescriptionJoin Beacon Therapeutics (USA) Inc.Full-Time Clinical Operations Manager and contribute to groundbreaking advancements in the biotech industry remotely in the USA.This... Show more

 • Promoted

Travel MRI Tech - $2797.6 / Week

Medical SolutionsSalem, MA, US
Full-time

Medical Solutions is seeking an experienced MRI Tech for an exciting Travel Allied job in Salem, MA.Shift: 3x12 hr nights Start Date: 07/05/2026 Duration: 13 weeks Pay: $2797.A facility in Salem, M... Show more

 • Promoted

Clinical Project Manager II - Virology (Sponsor Dedicated - US Remote;Preference for Hybrid Foster

Syneos Health/ inVentiv Health Commercial LLCBoston, MA, US
Remote
Full-time

Clinical Project Manager II - Virology (Sponsor Dedicated - US Remote; Preference for Hybrid Foster City, CA).Syneos Health is a leading fully-integrated life sciences services organization built t... Show more

 • Promoted

Travel CT Tech in Lawrence, MA

AlliedTravelCareersLawrence, MA, US
Full-time

Competitive weekly pay (inquire for details) .ARRT(CT)/BCLS/BLS - American Heart Association.Titan Medical is looking for travelers to fill a Travel CT Technologist position for a 13-week assignmen... Show more

 • Promoted

Travel Nurse - RN - Cath Lab - $2695.8 / Week

Atlas MedStaffSalem, MA, US
Full-time

Atlas MedStaff is seeking an experienced Cath Lab Registered Nurse for an exciting Travel Nursing job in Salem, MA.Shift: 4x10 hr days Start Date: ASAP Duration: 13 weeks Pay: $2695.Atlas Medstaff ... Show more

 • Promoted

Travel CT Tech - $2819.96 / Week

Ventura MedStaffLawrence, MA, US
Full-time

Ventura MedStaff is seeking an experienced CT Tech for an exciting Travel Allied job in Lawrence, MA.Shift: Inquire Start Date: 06/22/2026 Duration: 13 weeks Pay: $2819.Founded in 2018 and located ... Show more