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Reference # : 18-37582 Title : Clinical Trials Management Associate - II
Location : Foster City, CA
Experience Level : Start Date / End Date : 07/16/2018 / 01/15/2019  
Description
Job Title: Clinical Trials Management Associate - II
Work Location: Foster City, CA
Length of Assignment: 6 Months
Position Type: Contract Full Time
Client:  A Big Pharmaceutical Company


Senior Clinical Trials Management Associate (Sr. CTMA) Biomarker Operations

Specific Responsibilities and Skills for Position:
- Must meet all requirements for Clinical Trials Management Associate (CTMA) position and must have demonstrated proficiency in all relevant areas
- Serves as the key biomarker operational contact with internal and external stakeholders, for successful implementation of biomarker strategy in  (Client) and Collaborative (CO) programs
- Participate in multiple Phase 1-3 teams to manage biomarker implementation in clinical trials
- Plans and coordinates all operational activities required with the collection, delivery and analysis of biomarker samples within a clinical trial
- Provides sample management expertise to the Study Management Teams (SMTs)
- Accountable for ensuring biomarker samples collected are of good analyzable quality and are collected in adherence to the highest standards of ethics and informed consent.
- Collaborate with biomarker biology to translate sample processing and handling instructions from research setting to the clinical setting
- Primary interface for operational activities between the SMT and biomarker laboratory vendors; Provides the day-to-day operational management of biomarker vendors to ensure
delivery against contracted scope of work
- Able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions
- Participate in or manage project meetings and conference calls with CROs, vendors, and multi-functional teams
- Able to anticipate obstacles and proactively develop solutions to achieve project goals
- Develop a general understanding of functional issues and routine project goals from an organizational perspective
- Participate oral presentations as applicable
- Interact and cooperate with individuals in other functional areas to address routine study issues
- Develop tools and processes that increase measured efficiencies of the project
- Assist in trainings for Clinical Trials Management Associates (CTMAs) and Clinical Project Assistants (CPAs),
- Assist in selecting Contract Research Organizations (CROs) or vendors as needed
- Assist with the setting and updating of study timelines
- Participate in departmental, or interdepartmental, strategic initiatives under general supervision
- Conduct vendor visits and provide site training, as needed under general oversight
- Ensure that the site complies with the protocol and regulatory requirements for Client studies
- Review of protocols, informed consents, and relevant study documents
- Travel may be required

Knowledge:
- Excellent verbal, written, interpersonal and presentation skills are required
- Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies
- Working knowledge and experience with Word, PowerPoint and Excel

Experience and Skills:
-At least 3+ years of experience and a BS or BA in a relevant scientific discipline (eg. Clinical Operations and/or Sample Management) or
-At least 3+ years of experience and an RN (2 or 3 year certificate)
-Pharmaceutical industry experience or experience working as a clinical trial
coordinator within a clinical trial setting is a plus
-Clinical or biological laboratory experience with evidence of involvement in the
processing and/or analysis of biological samples is a plus

If you are interested in this job than please send me your most updated resume on reena.sangwan@artech.com or you can reach me at #973-507-7579