Precisionmedicinegroup
Senior Clinical Data Manager
Remote, Brazil; Remote, Colombia; Remote, Mexico. Posted 18 days ago
The role
The Senior Clinical Data Manager manages all aspects of the clinical trial data management process from study start up to post database lock. This role involves overseeing database development, testing, and ensuring the delivery of high-quality clinical data.
What you will do
- Act as primary Data Management contact for assigned clinical projects
- Oversee project data entry process including guidelines, training, and quality
- Develop CRF specifications from clinical study protocols
- Conduct database build UAT and maintain documentation
- Create, revise, and maintain data management documentation
- Train clinical research personnel on study specific CRF and EDC
- Review and query clinical trial data according to the Data Management Plan
- Perform medical coding of medical terms
- Coordinate SAE/AE reconciliation
- Liaise with third-party vendors in a project-manager capacity
Required qualifications
- Bachelors and/or a combination of related experience
- 8+ years experience for a Sr. Clinical Data Manager or 10+ years for a Principal Clinical Data Manager
- Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
- Able to handle a variety of clinical research tasks
- Excellent organizational and communication skills
- Professional use of the English language, both written and oral
- Experience in utilizing various clinical database management systems
- Broad knowledge of drug, device and/or biologic development and effective data management practices
- Strong representational skills, ability to communicate effectively orally and in writing
- Strong leadership and interpersonal skills
- Ability to undertake occasional travel
Nice to have
- Experience in a clinical, scientific or healthcare discipline
- Dictionary medical coding (MedDRA and WHODrug)
- Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.)
- Oncology and/or Orphan Drug therapeutic experience
Before you apply
- Candidates must be legally authorized to work in the country of employment without employer sponsorship
About the company
Precision Medicine Group is an Equal Opportunity Employer expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru.