A Clinical Operations Manager role inSan Diego,CAneeds to be filled immediately by Adecco Medical & Science. In this role you will support GCP Operations by helping to manage clinical trials and work closely with and be part of multi-department project team.
CLINICAL OPERATIONS MANAGER JOB RESPONSIBILITIES
Maintain clinical trial master file ensuring both regulatory documents and source documents are filed properly.
Coordinate generation of clinical databases and ensure related data transfer activities are appropriate for business partners.
Update and/or generate internal SOPs to ensure GCP compliance.
Ensure testing sites and collection sites are trained on study specific instructions.
Responsible for coordinating with Operations for worldwide logistical set up for distribution of study supplies related to various clinical studies.
Help organize and coordinate the logistics for the ambient/cold/frozen sample shipments to arrive to the laboratories within expected turn-around times.
Assist in arranging import and export license for LabPMM testing labs in North America, EU, andAsia, when needed.
Help to reconcile supply kits, request forms, shipping documents, etc. to demonstrate proper traceability in the clinical trial master file.
Coordinate monitoring of clinical site activities in compliance with the trial protocols.
Create and submit clinical site documentation for obtaining IRB or IEC approvals.
Clinical Operations representative to business partners, clinical sites and investigators.
Cooperates and respectfully communicates with external and internal customers
Bachelor's degree with 5+ years of experience
Experience coordinating and/or monitoring clinical trials.
Familiar with data management and Laboratory Information Management Systems (LIMS) is considered a plus.
Familiar with general laboratory safety procedures.
Excellent interpersonal communication and experience with working with multiple locations.
Strong computer skills across common general office applications.
Strong attention to detail and organizational skills with good record keeping and multi-tasking abilities
Analytical and problem solving skills
If you are interested in this then please click APPLY NOW. For other opportunities available at Adecco Medical and Science go to www.adeccousa.com or email your resume to Melody.Lam@adeccona.com
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
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