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PTC Therapeutics
Warren, United States
163,800 – 206,200 USD
per year
Title: Associate Director, Clinical Data Management Location: USA - New Jersey - Warren
Location: USA - New Jersey - Warren Workplace: Hybrid Employment: Full time PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease. At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging. Visit our website to learn more about our company and culture!
Job Description Summary:
Job Description: Candidates local to the Warren, NJ area are strongly preferred for our flexible hybrid work model. We welcome applicants who are open to relocating to the area. The Associate Director, Clinical Data Management is responsible for providing leadership and oversight of data management activities to ensure accuracy and consistency of clinical databases for subsequent analysis and reporting. This position has a leadership role to proactively develop plans for the utilization of EDC system processes and other clinical data applications that allow for internal control of clinical databases. This position will assist in defining Sponsor processes and procedures for maintaining clinical data and the associated QA/QC Documentation. She/He may have supervisory responsibilities for both internal staff and external consultants. They may also manage direct reports and work cross-functionally with various internal departments and external resources on Data Management related issues. The Associate Director, Clinical Data Management, supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
ESSENTIAL FUNCTIONS
Primary duties/responsibilities:
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
Minimum level of education and years of relevant work experience. 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.
Special knowledge or skills needed and/or licenses or certificates required. 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.
*Special knowledge or skills and/or licenses or certificates 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.
Expected Base Salary Range $163,800 - $206,200. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity. In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC’s medical, dental, vision, and retirement savings plans.
EEO Statement: PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
RocketHunt estimate from real salaries
Grade
Director
Experience
from 8 years
Work Format
Hybrid
Employment
Full-time
English Level
C1 - Advanced
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