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Bridgeway 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 ProfessionalsToni 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, LLCViridian 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 DynamixDyne 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 TxActalent
Waltham
Job Title: Associate Director, Clinical Data ManagementJob Description We are seeking an experienced Associate Director of Clinical Data Management to define and lead our data management strategy. Reporting to the Senior Director, this pivotal role will oversee the start-up and execution of multiple, complex trials in collaboration with a Contract
Job Source: ActalentDyne 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 TherapeuticsViridian 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, IncWaltham, 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 multiple, complex trials with a CRO and supporting upcoming submissions. The individual will coordinate and manage daily data management and vendor oversight activities for multiple clinical trials to support both the internal project team and the CROs.
This role is based in our Waltham, MA headquarters. Our office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH)
Responsibilities (including, but not limited to) :
Drive and lead the development of all databases and eCRF design
Plan, develop and implement UAT (user acceptance testing), data specifications, data entry guidelines, CRF completion guidelines, and related operational manuals/guidelines
Develop and execute data validation guidelines and measures to ensure accurate data gathering from clinical studies
Review and provide expertise on all eCRF changes, respond accordingly to make resulting database changes
Organize and direct the initial stage of the studies, review and sign off on various items such as eCRF, data validation, data review guidelines, and data management plans
Oversee and build strong sustainable relationships with multiple global CROs/vendors along with managing the process and coordination of each
Accountable for ensuring all data quality and timeliness of CDM deliverables are met and aligned with the business goals; Coordinate with all functions to drive data cleaning
Review, track, and report status of all data management project(s) to senior leadership
Responsible for managing the clinical trial data queries along with the planning and execution of medical coding and SAE reconciliation
Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF)
Partner with cross functional key stake holders to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting; Serve as internal expert on data management with vendors
Develop data management SOPs and processes that align and address business priorities; Contribute to cross-functional SOP development
Uphold a reputation for data integrity and compliance
Requirements
Requires a Bachelor’s degree within a scientific discipline (advanced degree a plus) with a minimum of 10+ years of experience within biotech/biopharma and/or CRO organization
Extensive knowledge and experience in clinical data management
Direct experience with different Data Management systems and technologies, Electronic Data Capture systems and CDISC data standards
Extensive knowledge reviewing study planning documents such as Edit Check Specs, UAT scripts, Data Management Plans
Comprehensive understanding of database and dictionary structures (e.g., MedDRA, WHO DRUG)
Deep understanding of drug development, study conduct processes, GCP and regulations related clinical data management as well as ICH guidelines, FDA/EU regulations
Demonstrated experience in managing multiple CROs/vendors
Demonstrated strong written and verbal communication skills
Proven mindset of proactive continuous improvement
Efficient independent worker with ability to focus and drive for results
Strong attention to detail
Ability to work in a fast paced-environment and to handle multiple tasks
Strong commitment to ethical standards
Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
The salary range for this position is commensurate with experience
Apply Unless noted above, applicants MUST be authorized to work in the US without Visa Sponsorship. US citizens and Green Card holders ONLY. We do not provide relocation assistance for those living outside the continental US. Please only click apply if you meet the specific requirements of the job listing, you are able to work in the location listed, and are comfortable with the salary range indicated above. Thanks for your interest. We look forward to working with you.
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Email Alert for Associate Director, Clinical Data jobs in Waltham, MA, United States
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