Society for Clinical Data Management

Senior Manager, Clinical Data Management

Fulcrum Therapeutics
Cambridge, Massachusetts, United States
7 days ago

Description

* Fulcrum requires all employees to be fully vaccinated against COVID-19.  This requirement is a condition of employment at Fulcrum, and it applies regardless of whether or not the position is located onsite at Fulcrum’s headquarters in Cambridge, MA.  If you are unable to receive the vaccine due to a serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

Company Overview 

Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum’s two lead programs in clinical development are losmapimod, a small molecule for the treatment of facioscapulohumeral muscular dystrophy (FSHD) and FTX-6058, a small molecule designed to increase expression of fetal hemoglobin for the treatment of sickle cell disease and other hemoglobinopathies, including beta-thalassemia. The company’s proprietary product engine, FulcrumSeekTM, identifies drug targets that can modulate gene expression to treat the known root cause of gene mis-expression.

Description

This role reports to the Head of Biometrics. The Senior Manager, Clinical Data Management (CDM), will provide data management support to clinical studies within the Biometrics function, and would be responsible for all CDM related areas/activities for clinical studies assigned.



Requirements

Responsibilities

  • Participates in study level vendor oversight activities. May represent data management function on the Clinical team ensuring aligned expectations between the CRO and Fulcrum for all data management deliverables.
  • Serves as a first point of contact for CRO partners when collaboration is needed to ensure established milestones and deliverables are met with the highest degree of quality.
  • Manages end-to-end (start-up to database lock) delivery of data management services while complying with Good Clinical Practices, applicable regulatory guidelines, company SOPs, Work Instructions, and policies.
  • Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks.
  • Works with other functions to complete set-up of EDC and other study data collection tools such as IRT, ePRO and eCOA.
  • Leads the creation and maintenance of study data cleaning plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plan(s), coding guidelines, SAE reconciliation guidelines, database lock plans.
  • Leads data review, including query management, and leads activities required for interim and final database locks.
  • Participates in preparing for submission readiness and may represent function in a formal inspection or audit.
  • Ensures archival and inspection readiness of all Data Management documents in Trial Master File (TMF)
  • Tracks study deliverables and evaluates study metrics to mitigate risk for major data management deliverables and milestones.
  • May prepare metrics to support the function's KPIs.
  • Contributes to functional Continuous Improvement initiatives, providing expertise and ensuring deliverables are provided on time, to budget, and in alignment with company, departmental or functional requirements.
  • Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables.
  • Performs other duties as assigned.

Qualifications

  • BS/BA required preferably in a health-related, life science area or technology-related fields.
  • Preferred 4-6 years of experience in data management and/or drug development process with expertise in the cross-functional interfaces.
  • Proven track record of strong project management skills and experience managing data management activities for large drug development programs.
  • NDA/CTD Experience preferred.
  • Strong knowledge of data management best practices & technologies as applied to clinical trials.
  • Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
  • Strong knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
  • Good understanding of CDISC standards. Some experience in standards development, implementation and maintenance is ideal.
  • Strong knowledge of relational databases and experience using multiple clinical data management systems.
  • Vendor Management experience

Job Information

  • Job ID: 62204251
  • Location:
    Cambridge, Massachusetts, United States
  • Position Title: Senior Manager, Clinical Data Management
  • Company Name For Job: Fulcrum Therapeutics
  • Job Function: Data Management
Biotechnology
Cambridge , Massachusetts , United States

Fulcrum Therapeutics is focused developing new medicines to deliver a new future for patients and their families by transforming gene regulation in disease. The Fulcrum product engine is based on the breakthrough biology of gene regulation. It will bring to bear medicines for devastating diseases across multiple therapeutic areas by modulating – or balancing – the expression of the genes known to drive disease. The Fulcrum product engine integrates insights from four scientific disciplines: Gene Regulation, Human Genetics a...

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