Director, Clinical Data Management

About TrialSpark

On a mission to bring new treatments to patients faster and more efficiently 

Founded in 2016, TrialSpark is a tech-driven Pharma company differentiated by radically more efficient drug development. TrialSpark has built a technology platform that optimizes all aspects of clinical drug development, enabling more efficient trial design, faster trial completion, and higher quality trial data. 

The company acquires clinical-stage drugs from pharmaceutical and biotech companies and develops them faster, unlocking greater value per program and accelerating access to new treatments for patients. TrialSpark's current therapeutic areas of focus include rheumatology, dermatology, CNS, and cardiometabolic diseases.

About the Position

The Director of Clinical Data Management (CDM) will report to VP, Biostatistics and serve as a key leader to support the clinical development at TrialSpark. The Director of CDM will lead all clinical data management activities across different therapeutic areas. In addition, the Director of CDM will build and lead a high-performing clinical data management team at TrialSpark.

Responsibilities

• Manage clinical data management activities of all TrialSpark studies to ensure quality and compliance of deliverables.
• Demonstrate subject matter expertise in all aspects of the CDM discipline, driving the team’s strategy, capabilities, systems, and deliverables. 
• Build and lead a high-performing CDM team at TrialSpark including full time employees, contractors, and third-party vendors.
• Manage the CDM team at TrialSpark, assume primary accountability and oversight for CDM supports.
• Identify CDM resource needs based on project milestones and deliverables, ensure adequate long-term resource allocation to support all clinical programs.
• Partner with the Clinical Data Programming (CDP), Product and Engineering teams in the definition of system requirements for internal technology products including eSource, ePRO, and EDC systems.
• Partnering with the CDP, Product and Engineering and other teams to develop CDM workflows to integrate data within the internal and external technology products.
• Lead the development and implementation of clinical data standards, SOPs and other guidance documents, and ensure CDM activities are performed in high-quality following GCP and SOPs. 
• Ensure that CDM deliverables meet the regulatory requirements and company standards.

About You 

• A track record of leading high performing CDM teams.
• Extensive experience with varying study types and phases. 
• Solid understanding of clinical trial design, analysis activities, regulatory guidelines, CDISC standards, and eCTD submission requirements.
• Strong computer skills, including database management software, reporting tools, medical coding tools, etc.
• Experience with EDC, eCOA, IRT, and other study systems/devices, vendor selection, and the implementation of such systems.
• Strong knowledge of medical terminology, including implementation and use of the WHO Drug and MedDRA dictionaries.
• Thorough knowledge and understanding of 21 CFR, Part 11, International Council of Harmonization E6(R2), Good Clinical Data Management Practice (GCDMP), and applicable federal and international regulations and guidance.
• Expertise in the clinical technology landscape including software and digital systems used in clinical research.
• Critical thinking skills with the ability to rethink legacy assumptions in the clinical research space and develop efficiencies wherever possible.
• Cross-functional partnership skills and the ability to work across an organization’s functional groups to achieve objectives and meet timelines.
• Solid written and oral communication skills with the ability to synthesize complex concepts and deliver messages clearly.

Required education and experience

• 7+ years of Data Management experience in pharmaceutical / biotech industry and / or CRO.
• 4+ years in a Data Management leadership role
• BS required, preferably in life sciences, computer sciences or a related field.

Preferred education and experience

• CCDM certified or GCDMP expertise preferred.

We offer competitive compensation because we want to hire the best people and reward them for their contributions to our mission. We pay all employees competitively relative to the New York City market, regardless of their location. In compliance with NYC’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open roles at TrialSpark. The target salary range for this role is $200,000 - $255,000.

On top of base salary, we also offer equity, generous perks, location flexibility, and comprehensive benefits – learn more about them and our compensation philosophy here.

If this range doesn’t match your expectations, please still apply because we may have something else for you.

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.