Email Alert for
ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.
Viridian Therapeutics, Inc
Waltham, MA, United States
Description At Viridian Therapeutics, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets. Reporting to the
Job Source: Viridian Therapeutics, IncViridian Therapeutics
Waltham, MA, United States
Job Type Full-time Description At Viridian Therapeutics, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team's expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated tar
Job Source: Viridian TherapeuticsClinical Dynamix
Boston, MA, United States
ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH) Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical d
Job Source: Clinical DynamixCameron Craig Group
Waltham, MA, United States
ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization. The Associate Director, Clinical Data Management is responsible for overseeing the start-up and execution of multipl
Job Source: Cameron Craig GroupToni Group, LLC
Waltham, MA, United States
ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization. The Associate Director, Clinical Data Management is responsible for overseeing the start-up and execution of multipl
Job Source: Toni Group, LLCBridgeway Professionals
Waltham, MA, United States
ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization. The Associate Director, Clinical Data Management is responsible for overseeing the start-up and execution of multipl
Job Source: Bridgeway ProfessionalsDyne Therapeutics
Waltham, MA, United States
Company Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle
Job Source: Dyne TherapeuticsDyne Tx
Waltham, MA, United States
Our commitment to people with muscle diseases is our greatest strength Associate Director, Clinical Data Analyst Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.With its proprietary FORCE platform, Dyne is developing moder
Job Source: Dyne TxBoston, MA, United States
Company Overview
Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.
Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.
This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.
The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts
Summary
Reporting to the Vice President, Biometrics, the Associate Director of Clinical Data Management will be responsible for leading the clinical data management processes across Tango's clinical trials. This will include clinical trial planning through data generation and database lock. This position will initiate best practices and lead clinical data management process flow as well as support the oversight of data management vendors, data transfers and data handling.
Your role:
You will manage the clinical data management partnership with clinical CROs for Tango's clinical trials
Provide oversight for fully outsourced clinical data management activities from RFP to final database lock by working effectively with CRO partners to develop and standardize data handling plans, data transfer specifications, metrics, and data review tools
Develop and/or write the database design, edit checks, CRF completion guideline, and Data Management Plan for in-house data management activities ensuring CDASH and SDTM standards
Work with cross functional team members to standardize data collection and reporting
Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, specialty labs, etc.) to ensure that project timelines and goals are met effectively, and within budget
Attend study team meetings to provide updates and issue resolution in terms of data collection through analysis
Work collaboratively with cross functional team members to ensure clinical data is ready for early phase deliverables in stream
Support a Tango eCRF library and database build configuration
Additional duties and responsibilities as required
What you bring:
Bachelor's degree in computer science, or a science-based subject with at least 8 years of clinical data management experience in industry, with experience across indications and EDC platforms
At least three years of management experience in a clinical research environment, most of which should be in industry and preferably across therapeutic areas including oncology
Strong vendor management and oversight experience
Solid technical skills across data platforms; programming experience preferred
Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology
Cross collaboration proficiency with other related functions such as Biostatistics, Statistical Programming, and Pharmacovigilance
Understanding of FDA and ICH GCP guidelines to ensure appropriate reporting of clinical trial data
Experience in regulatory GCP inspections/audits preferred
Experience with Spotfire, eluminate or other data visualization software
Ability to manage multiple projects in a fast-paced environment
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
#J-18808-Ljbffr
Email Alert for Associate Director, Clinical Data Management jobs in Boston, MA, United States
ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.