Senior Manager, Clinical Data Management

PTC Therapeutics•Warren, MI

6d•Hybrid

About The Position

The Senior 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 may have oversight responsibilities of external consultants. This position will assist in defining Sponsor processes and procedures for maintaining clinical data and the associated Quality Assurance/ Quality Control (QA/QC) Documentation. She/He will work cross-functionally with internal departments and external resources on Data Management related issues. The Senior Manager, Clinical Data Management supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Requirements

Bachelor’s degree in science or related field (such as healthcare) with a minimum of 7 years of relevant progressively responsible experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions.
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, 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 understanding and application of regulatory requirements and relevant data standards.
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.

Nice To Haves

MedDRA and WHO Drug coding proficiency is preferred.
Experience with Medidata RAVE is desired.
CDISC and SDTM knowledge and experience are preferable.

Responsibilities

Responsible for ensuring the data collected meets the requirements of the study objective and company quality standards.
Work closely with clinical research organizations (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 clinical report forms (CRF's) 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 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.
Contribute to development of outsourcing strategies and relationships with outsourcing partner and may play a role in identification of quality DM partners.
Performs other tasks and assignments as needed and specified by management.