Associate Director/Director, Clinical Data Management

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 Director, 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.

Responsibilities

• Act as primary liaison between Fulcrum and CRO for Data Management.
• Provide support and oversight for the CRO Data Management team.
• Collaborate with the team on study design, protocol development, CRF design, statistical planning, and CSRs.
• Review clinical study protocols and provide comments if any.
• Provide leadership and support for cross-functional tasks, processes, and training.
• Provide oversight and manage relationships with external vendors.
• Responsible for reviewing the data management documentation, data management plan (DMP), CRF, study database specifications, data validation plan, edit check specifications, data transfer specifications, data issue logs, data review plans and ensures all documents follow study design and regulatory requirements.
• Perform User acceptance testing for EDC and make sure all the comments have been resolved prior to DB going live.
• Responsible for all CDM activities including but not limited to database go live, data review, database lock.
• Monitor data cleanup activities performed by CRO.
• Review metrics, listings provided by CRO and follow up for any action needed.
• Participate in Study Management team calls representing CDM.
• Responsible for ensuring data transfers between vendors and/or Sponsor as per DTS.
• Participate in data review along with biostatistics and statistical programming team.
• Assist other data managers in performing data management activities.
• Provide oversight for Information Technology, Quality Assurance teams and assume a lead role for assigned activities.
• Ensure project objectives meet quality acceptance criteria.
• Plan, implement, and manage operational and financial aspects of data management tasks for global and domestic projects.
• Establish and maintain study timelines and tracking timelines, management of resources.
• Identify and manage team milestones and project risks.
• Develop SOPs and guidance documents related to departmental and organizational functions.
• Proactively identify potential challenges, risks and develop proposed solutions and/or contingency plans.
• Lead designated team meetings.
• Prepare and lead vendor audits as assigned.
• Mentor junior data managers.
• Support the selection of biometrics vendors.

Qualifications

• Master’s degree or higher in science or related discipline.
• Minimum of 11 years of CDM experience in pharmaceutical/biotech industry.
• Practical experience with successful submissions and product approvals from global regulatory authorities across multiple therapeutic areas.
• Thorough and broad knowledge of data management processes, including EDC and interactive web response system (IWRS) experience.
• Good working knowledge of regulatory guidelines such as GCP, 21 CFR Part 11, etc.
• Solid understanding of clinical research methods, Clinical Data Interchange Standards Consortium (CDISC) principles, best data management practices and technologies related to clinical trials.
• Excellent attention to detail with a strong professional commitment to high quality work.
• Ability to handle multiple studies simultaneously.
• Strong knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
• Proven success in a fast paced, entrepreneurial, smaller company environment is highly desired.
• Vendor management experience is essential.

Personal Characteristics

• Excellent interpersonal skills including developing relationships at all levels in an organization to influence business objectives.
• Commitment to working collaboratively and to building team and company culture.
• Analytical, strategic thinker with good problem-solving skills.
• Articulate and persuasive in both scientific and business forums.
• Effective written and verbal communication skills.
• Critical thinking.