Associate Director, Clinical Data Management

PTC Therapeutics, Inc.; New Jersey; Sur place; USD 163 800 - 206 200; Plein temps

Avantages offerts par ce poste

Medical, dental, vision plans

Retirement savings plans

Short- and long-term incentives

Résumé du poste

PTC Therapeutics, Inc. is seeking an Associate Director of Clinical Data Management to lead efforts ensuring the accuracy of clinical databases. This role combines leadership with a hybrid work model, and strong candidates are preferred in the Warren, NJ area. The position requires at least 8 years of experience in a pharmaceutical or biotech environment.

The ideal candidate will have extensive project management skills while overseeing clinical data applications, working with various departments, and demonstrating an understanding of regulatory requirements.

Qualifications

• Minimum of 8 years of relevant experience in pharmaceutical or biotech environments.
• Experience with vendor management using database technologies.
• Demonstrated leadership and experience managing direct reports.

Responsabilités

• Oversee data management activities, ensuring data accuracy and consistency.
• Develop and implement strategic vision for the Data Management group.
• Collaborate with CROs to ensure proper execution of data management plans.

Connaissances

Leadership

Project management

Data management

Communication

Analytical thinking

Formation

Bachelor’s degree in science or related field

Outils

Medidata

SAS

Oracle RDC

Description du poste

Job Description

Associate Director, Clinical Data Management provides leadership and oversight of data management activities to ensure accuracy and consistency of clinical databases for analysis and reporting. The role proactively develops plans for EDC system processes and other clinical data applications to allow internal control of clinical databases. This position assists in defining sponsor processes and procedures for maintaining clinical data and associated QA/QC documentation. This role may have supervisory responsibilities for internal staff and external consultants, manage direct reports, and work cross-functionally with various internal departments and external resources on data‑management related issues.

Candidate preferences: Candidates local to the Warren, NJ area are strongly preferred for our flexible hybrid work model. Relocation to the area is welcomed.

Essential Functions

• 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.

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.

In addition to base salary, employees are eligible for short‑ and long‑term incentives. Employees may enroll in medical, dental, vision and retirement savings plans.

Travel Requirements

5-15% travel.

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.