Manager, Clinical Data Management

Manager, Clinical Data Management

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.

The Manager, Clinical Data Management is responsible for providing oversight of data management activities to ensure accuracy and consistency of clinical databases for subsequent analysis and reporting. This position is responsible for database development, utilizing 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 will work cross-functionally with internal departments and external resources on Data Management related issues. The Manager, Clinical Data Management supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

The primary duties / responsibilities include :

• Ensuring the data collected meets the requirements of the study objective and company quality standards.
• Working closely with CROs to prepare and ensure proper execution of data management plans and manage data management projects from beginning to end.
• Working closely with Clinical Operations group, biostatisticians, SAS programmers and other staff as appropriate to develop Case Report Forms (CRFs) to ensure the required information is captured for statistical analysis.
• Responsible for data management activities, database cleaning and lock activities including developing data management plans, supervising database development, and reviewing and processing clinical trial data to ensure completeness, accuracy, and consistency of clinical trials databases.
• Preparing and distributing or facilitating distribution of periodic reports of study status including, CRF completion status, missing pages, query aging, etc.
• Participating in cross functional team meetings as requested and communicating with all departments regarding project statuses / issues, providing ongoing feedback on data management workflows to increase efficiency and providing feedback to Clinical Research Associates (CRAs).
• Leading interactions with outside vendors (e.g., clinical laboratories) on collection, transmittal, and transfer of study specific data.
• Contributing to SOP development and updates to meet regulatory compliance and operational needs.
• Participating in clinical review and validation of statistical outputs used in the preparation of final reports.
• Managing multiple and varied tasks, prioritizing workload with attention to detail.
• Understanding the legal and compliance environment and driving collaboration with the Legal and Compliance team.
• Driving the spirit of "ONE Team" across all functions by supporting a team approach to focus on our patients and customers as our top priorities.
• Leading the completion of data management activities to meet project timelines and communicating status to respective team members.
• Performing other tasks and assignments as needed and specified by management.

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) with a minimum of 6 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 :

Travel requirements : 5 - 15%

Expected Base Salary Range : $117,400 - $147,800. 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.