PTC Therapeutics, Inc. · 3 months ago
Associate Director, Clinical Data Management
USA - New Jersey - Warren
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$149K/yr - $188K/yr
8+ years expPTC Therapeutics is a global commercial biopharmaceutical company focused on extending life’s moments for those living with rare diseases. The Associate Director, Clinical Data Management is responsible for leading data management activities, ensuring the accuracy of clinical databases, and collaborating with various teams to support clinical trials. This role includes managing projects, mentoring staff, and ensuring compliance with regulatory requirements.
BiotechnologyHealth CareTherapeutics
Responsibilities
Ensure the data collected meets the requirements of the study objective and company quality standards
Assist in the development and implementation of strategic vision for data management (DM) group
Collaborate with CROs to prepare and ensure proper execution of data management plans and manage data management projects from beginning to end
Work closely with Clinical Operations group, biostatisticians, SAS programmers and other staff as appropriate to design and develop data collection instruments (e.g., eCRF's) to ensure the required information is captured for statistical analysis
Oversee coding review for adverse events, medical history and concomitant medications and coordinate medical monitor review and approval of medical coding
Lead data management activities, clinical database cleaning in EDC, data reconciliation with external vendor data, SAE reconciliation and lock activities
Lead development of data management plans, data review plans, supervise database development, and reviewing and processing of clinical trial data to ensure completeness, accuracy, and consistency of clinical trials data
Prepare and distribute or facilitate distribution of periodic reports of study status including, case report form (CRF) completion status, missing pages, query aging, clean patient tracker (CPT), etc
Participate in cross functional team meetings, as requested, and communicate with all departments regarding project statuses/issues, provide ongoing feedback on data management workflows to increase efficiency and provide feedback to CRAs
Lead interactions with outside vendors (e.g., clinical laboratories) on collection, transmittal, and transfer of study specific data
Develop and update SOP's and other documents associated with the data collection, handling, and review processes, e.g., Working Instructions (WI), Best Practices Documents (BPD)to meet regulatory compliance and operational needs
Participate in clinical review and validation of statistical outputs used in the preparation of final reports
Mentor clinical team members by resolving problems and providing DM guidance
Manage multiple and varied tasks, prioritize workload with attention to detail
Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
Drive the spirit of “ONE Team” across all functions by supporting a team approach to focus on our patients and customers as our top priorities
Lead the completion of data management activities to meet project timelines and communicate status to respective team members
Contribute to the development of outsourcing strategies and relationships with outsourcing partner and may play a role in identification of quality DM partners including coordinating the review and approval of the Master Services Agreement
May manage, coach, and mentor direct reports
Performs other tasks and assignments as needed and specified by management
Qualification
Required
Bachelor's degree in science or related field (such as healthcare) and a minimum of 8 years of relevant progressively responsible experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions
Experience in second-line management and functional leadership
Previous leadership of vendor management experience using Interactive Web Response System (IWRS), Imaging, Patient Reported Outcome (PRO) and other database technologies
Highly detail oriented while maintaining work efficiency, able to prioritize activities across various projects at different study stages
Knowledge of industry standards, such as the ICH guidelines, CDASH, 21 CFR Part 11, and FDA guidelines
Understanding of drug development process and data operations required for the reporting of clinical trial data (e.g., data review, study reports, regulatory submissions, safety updates, etc.)
Strong verbal and written communication, decision-making, influencing, negotiation, and project management skills
Technical skills and experience using Medidata or relational databases (e.g., Oracle RDC, InForm, Veeva EDC) and data visualization tools (e.g., Spotfire, J-Review, Business Objects)
Proficiency in the use of Microsoft Office Suite of tools (Word, Excel, etc.)
Learning agility and ‘scalability' to take on increasing responsibility Excellent time management, flexibility, ability to coordinate workload and meet established deadlines
Ability to influence without direct authority
Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
Preferred
Minimum five (5) years' experience with Medidata RAVE(EDC, R2DS/RBS, Architect)
Experience with Medidata RAVE
Strong understanding and application of regulatory requirements and relevant data standards; CDISC knowledge and experience
Experience in PL/SQL, SAS, Java, C++ relational database design and database programming skills preferred
Benefits
Short- and long-term incentives
Medical, dental, vision, and retirement savings plans
Company
PTC Therapeutics, Inc.
PTC is a patient-centered biopharmaceutical company focused on discovering, developing & commercializing medicine for children and adults living with rare and serious disease.
501-1000 employees
H1B Sponsorship
PTC Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (9)
2023 (14)
2022 (31)
2021 (13)
2020 (6)
Funding
Current Stage
Public CompanyTotal Funding
$1.57BKey Investors
Brookside CapitalCredit Suisse First Boston
2022-10-27Post Ipo Equity· $1B
2020-05-14Post Ipo Equity· $140.95M
2015-08-14Post Ipo Debt· $150M
Leadership Team
Matthew B. Klein
Chief Executive Officer and President
Stuart Peltz
CEO
Recent News
2026-01-03
2026-01-02
2025-12-24
Company data provided by crunchbase