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!
Site: www.ptcbio.com
ESSENTIAL FUNCTIONS
Primary duties/responsibilities:
Responsible for ensuring the data collected meets the requirements of the study objective and company quality standards.
Work closely 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 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.
Prepare and distribute or facilitate distribution of periodic reports of study status including, CRF completion status, missing pages, query aging, 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 Clinical Research Associates (CRAs).
Lead interactions with outside vendors (e.g., clinical laboratories) on collection, transmittal, and transfer of study specific data.
Contribute to SOP development and updates to meet regulatory compliance and operational needs.
Participate in clinical review and validation of statistical outputs used in the preparation of final reports.
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.
Performs 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.
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, 21 CFR Part 11, and FDA guidelines.
Experience with Medidata RAVE is desired.
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 understanding and application of regulatory requirements and relevant data standards; CDISC and SDTM knowledge and experience are preferable.
Strong communication (written and oral), decision-making, influencing, negotiation, and project management skills.
Technical skills and experience using Medidata or relational databases (e.g., Oracle InForm, MS SQL Server or MS Access) and data visualization tools (e.g., Spotfire, J-Review).
Proficiency in the use of Microsoft Office.
Excellent verbal and written communication skills.
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.
* 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.