Us PTC Therapeutics

Us PTC Therapeutics

Director, Clinical Data Management

USA - New Jersey - Warren · Director · Contract

Sponsorship not specified$201k-$253kDetected 32 days ago
JavaC++SQLData VisualizationComplianceProject ManagementNegotiationExcelVendor ManagementICD-10Clinical TrialsFDA RegulatorySASLeadershipCommunicationCollaborationProblem SolvingTime ManagementMentoringMicrosoft OfficeGxP

About the role

  • 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.
  • We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Responsibilities

  • Provide functional oversight of CROs to prepare and ensure proper execution of data management plans and manage data management projects from beginning to end.
  • 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.
  • 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.
  • Leads the assessment and selection of Data Management vendors and systems for clinical data collection and analysis.
  • 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.
  • 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.

Requirements

  • 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.).

Nice to have

  • We welcome applicants who are open to relocating to the area.
  • The incumbent works cross-functionally with various internal departments and external resources on Data Management related issues.
  • The Director, Clinical Data Management, ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Skills

  • Minimum level of education and years of relevant work experience.
  • 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, CDASH, 21 CFR Part 11, and FDA guidelines.
  • Strong verbal and written communication, decision-making, influencing, negotiation, and project management skills.
  • Proficiency in the use of Microsoft Office Suite of tools (Word, Excel, etc.).
  • Ability to influence without direct authority.
  • Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Knowledge of different regulatory standards and requirements, including but not limited to FDA, EMEA, and PMDA.
  • Minimum five (5) years' experience with Medidata RAVE (EDC, R2DS/RBS, Architect, Coder).
  • Strong understanding and application of regulatory requirements and relevant data standards; CDISC knowledge and experience.

Compensation

  • Expected Base Salary Range

Benefits

  • Drives the development and implementation of strategic vision for data management (DM) group.
  • Oversee and as needed, directly support coding review for adverse events, medical history and concomitant medications and coordinate medical monitor review and approval of medical coding

Company info

  • 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.
  • Visit our website to learn more about our company and culture!
  • 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.

Equal opportunity

  • PTC Therapeutics is an equal opportunity employer.
  • We are committed to treating all applicants fairly and avoiding discrimination.
  • Click here to return to the careers page
  • 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.

Visa & Work Authorization

  • This position will lead/contribute in defining Sponsor processes and procedures for maintaining clinical data and the associated Quality Assurance (QA) Quality Control (QC) documentation
Apply directly at Us PTC Therapeutics →Create a free account for alerts like thisView Us PTC Therapeutics immigration profile

This listing is sourced directly from Us PTC Therapeutics's careers page and normalized into a canonical job model.