Global Study Associate
Location: South San Francisco California
Description: Genentech is employing Global Study Associate right now, this position will be placed in California. More complete informations about this position opportunity please read the description below. Responsible for providing operational support to multiple study teams through all phases of clinical study management (Plan, Start-up, Conduct, and Close-out) in accordance with appropriate ! quality standards including ICH/GCP and applicable regulations.
Main Responsibilities and Accountabilities:
Provides operational support to multiple global study management teams (SMTs)
Develops and maintains effective working relationships with members of the SMT involved in running clinical studies such as GSMs, GSLs, affiliate team members, CRO partners and vendors.
Assists the GSM with effective communication and information sharing within the SMT and with external partners. Responsible for reviewing and maintaining accurate study level progress information and the efficient use of systems, tools and reports.
Contributes to the development, set up and maintenance of study specific tools.
Reviews standard study related reports and liaises with accountable study members to address any inconsistencies and missing information, as appropriate.
Ensures any data compliance or quality issues are escalated through the correct pat! hway.
Provides the SMT with guidance and know how to suppo! rt the effective use of system functionality and reports to ensure consistency across SMTs. Coordinates activities to ensure CRO and vendor delivery against the contracted scope of work
Responsible for communication between the study team and vendor for defined tasks and tracking information.
Trouble shoot issues ensuring vendor and CROs are working according to the contracted Scope of Work. Escalate to the study team as appropriate.
Ensure essential study information is tracked. Identifies and contributes to areas of best practice and process improvements
Proactively incorporates learning’s and recommendations from other study debriefs and best practices.
Promote standardization and foster improvements in efficiency in Study Management practices and processes ensuring consistent delivery across studies. Contributes to functional excellence activities
Participates in Product Development Operations initiatives and programs.
W! ho You Are
Qualifications:
Bachelor's degree with experience in a clinical research or health care related industry, or equivalent combination of education and experience. Life sciences degree or nursing equivalent is preferred.
Skills & Knowledge:
Experience
Knowledge of ICH/GCP
Experience of working as part of large team with a proven ability to make an active contribution to the team's performance and team working.
Proven effectiveness with written and verbal communication skills.
Proficient computer skills across multiple applications
Prioritizes and multitasks to ensure that tasks are completed on time
Self-motivated and displays initiative (resourceful) - for instance to move actions forward without the need for continual supervision. Competencies
Collaboration and Teamwork
Service/Customer Management
Personal Organization
Accuracy and Attention to Detail
Communication
Genentech is an Equal Opportunity Employer.
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If you were eligible to this position, please email us your resume, with salary requirements and a resume to Genentech.
If you interested on this position just click on the Apply button, you will be redirected to the official website
This position starts available on: Thu, 04 Jul 2013 01:09:46 GMT