Clinical Trials Management Associate II
Proclinical is recruiting for a Clinical Trials Management Associate for a leading pharmaceutical company located in Foster City, CA. Successful candidates will have knowledge of FDA/EMA regulation, experience with data entry, and proficiency with Microsoft Office, especially Outlook and Excel.
- Draft CRO email with results and attach all required forms.
- Send result email to CRO and/or Galapagos.
- Complete various SA trackers documenting SA information in a timely basis
- Provide updates/metrics to team as needed
- Assist in implementing routine activities and supports development of process improvement, if applicable
- Identify, track, and resolve routine queries and issues.
- Ongoing awareness of all ongoing SA visits.
- Process SA forms for all collections, review and data entry in EDC.
- Liaise with ClinOps, ClinResearch, Biostats, DM or Tulane for any issues arising from review of SA forms.
- Work with Biostats to ensure results are QC'd.
- Review resulting templates for accuracy.
- Demonstrates ability to identify problems early and communicate escalation issues appropriately.
- Capable of conducting assigned tasks independently.
- Effectively interacts and collaborates with Functional Areas representatives meet study deliverables and timelines for quality checking and reporting.
- Ensure completeness, accuracy and consistency of clinical data entry and reporting.
- Utilizes routine reports to track activity progress and ensures timeliness and quality expectations are met.
Skills and Requirements:
- Excellent verbal and written communication skills and interpersonal skills are required.
- Knowledge of FDA/EMA regulations and familiarity with web-based Electronic Data Capture (EDC) is a plus.
- Strong attention to detail and organizational skills, able to track and prioritize day to day activities.
- Proficient with Microsoft Office, specifically Outlook and Excel. Knowledge of Excel pivot tables, formulas a plus.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Catherine Nguyen at (+1) 215-531-5643 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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