The Senior Clinical Data Manager will serve in a support‐level capacity on a Clinical Data Management team to provide efficient and quality clinical data management products.
What will you be doing?
- The Senior Clinical Data Manager will serve in a support‐level capacity on a Clinical Data Management team to provide efficient and quality clinical data management products.
- Support the design, specifications, and development of eCRFs, ensuring adherence to Biogen standards throughout.
- Coordinate the development and testing of clinical data management systems edit checks and listings/reports/tools for data review and discrepancy management activities.
- Support the development of Data Management Plan documents that will ensure deliver y of accurate, timely, consistent, and high‐quality clinical data. Works with Third Party /External data Vendors to complete the set‐up of data import and reconciliation processes.
- Perform comprehensive review of all data generated from the clinical study including Third Party/External data, SAE data and local lab data, as applicable.
- Oversees quality control procedures. Develop and maintain strong communications and working relationships with CDM team.
- With guidance from Principal Clinical Data Lead or Manager, effectively manage project timelines and quality.
- Provide reports, status updates, feedback, and advice to key study stakeholders on the progress of data cleaning and risk identification/mitigation activities.
- Ensure CDM activities are performed in compliance with Good Clinical Practice, ICH Guidelines, Biogen SOPs, Job Aids, regulatory guidelines, and study specific plans.
- Apply appropriate best practices and independently offer project solutions to the study team.
- Ensures activities that are performed are done in line with study timelines, with quality and in compliance with governing process.
- Support the filing of eTMF documentation to ensure that an inspection ready environment is maintained throughout the study lifecycle.
- Supports and assists Subordinate staff for assigned trials. Impacts quality, timeliness, and effectiveness of the team. Provide back up support for Principal Clinical Data Lead as required.
Responsibilities
- Accountable for on‐time and comprehensive review of clinical study data listings, ensuring that all tasks are performed in according with Biogen processes, regulatory guidelines, and study specific plans. Impacts quality, timeliness, and effectiveness of the team
- Oversees and/or performs the reconciliation of key data points collected in EDC with other sources such as the Safety Database and Third Party/External Data Vendor.
- Communicates effectively across functions and organizations to ensure that all issues are resolved according to guidelines and requirements.
- Support the design and testing of technical CDM components including eCRFs, Edit Checks, reports, and listings.
- Manages the effective communication of data issues and discrepancies to study sites via the query management process.
- Escalates relevant issues to clinical study management team to facilitate timely resolution. Investigates and analyzes possible
solutions using experience, judgement and precedent, has autonomy to propose alternatives and exercises judgement based on experience.
- Delivery of comprehensive status reports and reporting of progress of DM activities, supporting the communication of data issues and trends to Study Management Team
- Supports the completion and management of Data Management documentation.
What do you need to have?
Education:
- Bachelor’s degree preferred, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
Experience:
- 4+ years of Clinical Data Management experience
- Ability to work under pressure demonstrating agility through effective and innovative team leadership
- Robust experience with EDC (E.g. Medidata Rave) and use of Data Review tools such as elluminate, J‐Review or Business Objects required
- Deep understanding of drug development and biopharmaceutical industry required
- Strong technical skills, including experience working with using Microsoft Excel functionality
- Fluent English (oral and written)
- Strong understanding of drug development and biopharmaceutical industry required
- High attention to detail including proven ability to manage multiple, competing priorities
- Excellent written and oral communication skills
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
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