Job description
ICON is looking for a Lead Data Manager to work dedicated to one of our FSP Clients!!
Responsibilities:
- Review, analyze, and validate clinical trial data throughout the study lifecycle to ensure data consistency, integrity, and accuracy based on project specific guidelines;
- Query data inconsistencies and revise case report forms in compliance with standard operating procedures (SOPs), protocol requirements, and regulatory agency guidelines;
- Generate and review reports and listings as required to maintain data integrity and reporting;
- Execute quality control activities such as preparing and carrying out internal database review, performing visual QC on data transfers and interim data reporting;
- Assist in cleaning data for study close out and perform database lock procedures;
- Execute a variety of administrative tasks including but not limited to filing, printing, formatting deliverables, creating binders and other study admin tasks as warranted;
- Develop and maintain study specific documentation and data management guidelines;
- Generate data retrievals and summaries as required;
- Provide accurate, timely, and consistent clinical data to internal staff to support business objectives;
Qualifications:
Bachelor’s Degree, preferably in life sciences;- Extensive clinical data management experience Pharmaceutical and/or CRO setting. 5-8 years’ experience in clinical data management;
- Proficient in Microsoft Word, Excel, and PowerPoint and EDC systems, preferable Medidata Rave;
- Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements;
- Excellent verbal and written communications skills;
- Strong interpersonal skills with demonstrated capability of working on multiple projects simultaneously;
- Ability to complete deliverables on time and adjust priorities in a fast-paced environment;
- Demonstrated ability to provide coaching and training to new hires and less-experienced staff;
- Comprehension of medical terminology desirable.
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.
seankuhnke.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, seankuhnke.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, seankuhnke.com is the ideal place to find your next job.