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Clinical Trials Management Associate - I

In California / United States

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Clinical Trials Management Associate - I   

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JOB TITLE:
Clinical Trials Management Associate - I
JOB TYPE:

JOB SKILLS:
JOB LOCATION:
Foster City California / United States

JOB DESCRIPTION :
Description:

Clinical Trials Management Associate (CTMA) Bioanalytical Operations

Specific Responsibilities and Skills for Position:

- Must meet all requirements for Clinical Project Associate (CPA) position in relation to bioanalytical sample analysis and must have demonstrated proficiency in all relevant areas
- Serves as the key bioanalytical operational contact with internal and external stakeholders, for successful implementation of bioanalytical strategy in Gilead (GS) and Collaborative (CO) programs
- Participate in multiple Phase 1-3 teams to manage bioanalytical implementation in clinical trials
- Plans and coordinates operational activities required with the collection, delivery and analysis of bioanalytical samples within a clinical trial
- Provides sample management expertise to the Study Management Teams (SMTs)
- Accountable for ensuring bioanalytical samples collected are of good analyzable quality and are collected in adherence to the highest standards of ethics and informed consent.
- Coordinate with bioanalytical vendors and Bioanalytical Chemistry staff to ensure bioanalytical sample long term stability to cover clinical trial samples
- Coordinate with bioanalytical vendors for bioanalytical sample storage and disposal
- Collaborate with bioanalytical partners to translate sample processing and handling instructions from research setting to the clinical setting
- Primary interface for operational activities between the SMT and bioanalytical laboratory vendors; provides the day-to-day operational management of bioanalytical 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 in 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 with the setting and updating of study timelines
- Participate in departmental, or interdepartmental, strategic initiatives under general supervision
- Participate in vendor visits and provide site training, as needed under general oversight
- Assist Gilead partners to ensure that the site complies with the protocol and regulatory requirements for GS studies
- Review of protocols, informed consent forms, and relevant study documents, as appropriate

Knowledge:

- Excellent verbal, written, interpersonal and presentation skills are required
- Knowledge of relevant FDA and/or EMA Regulations and Guidances (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 1+ years of experience and a BS or BA in a relevant scientific discipline (eg. Clinical Operations and/or Sample Management) or
-At least 1+ 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/analytical laboratory experience with evidence of involvement in the
processing and/or analysis of biological samples is a plus

Position Details

S16174661163403273
California / United States
Foster City
A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Clinical Trials Management Associate - I    Apply

Click on the below icons to share this job to Linkedin, Twitter!

Description:

Clinical Trials Management Associate (CTMA) Bioanalytical Operations

Specific Responsibilities and Skills for Position:

- Must meet all requirements for Clinical Project Associate (CPA) position in relation to bioanalytical sample analysis and must have demonstrated proficiency in all relevant areas
- Serves as the key bioanalytical operational contact with internal and external stakeholders, for successful implementation of bioanalytical strategy in Gilead (GS) and Collaborative (CO) programs
- Participate in multiple Phase 1-3 teams to manage bioanalytical implementation in clinical trials
- Plans and coordinates operational activities required with the collection, delivery and analysis of bioanalytical samples within a clinical trial
- Provides sample management expertise to the Study Management Teams (SMTs)
- Accountable for ensuring bioanalytical samples collected are of good analyzable quality and are collected in adherence to the highest standards of ethics and informed consent.
- Coordinate with bioanalytical vendors and Bioanalytical Chemistry staff to ensure bioanalytical sample long term stability to cover clinical trial samples
- Coordinate with bioanalytical vendors for bioanalytical sample storage and disposal
- Collaborate with bioanalytical partners to translate sample processing and handling instructions from research setting to the clinical setting
- Primary interface for operational activities between the SMT and bioanalytical laboratory vendors; provides the day-to-day operational management of bioanalytical 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 in 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 with the setting and updating of study timelines
- Participate in departmental, or interdepartmental, strategic initiatives under general supervision
- Participate in vendor visits and provide site training, as needed under general oversight
- Assist Gilead partners to ensure that the site complies with the protocol and regulatory requirements for GS studies
- Review of protocols, informed consent forms, and relevant study documents, as appropriate

Knowledge:

- Excellent verbal, written, interpersonal and presentation skills are required
- Knowledge of relevant FDA and/or EMA Regulations and Guidances (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 1+ years of experience and a BS or BA in a relevant scientific discipline (eg. Clinical Operations and/or Sample Management) or
-At least 1+ 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/analytical laboratory experience with evidence of involvement in the
processing and/or analysis of biological samples is a plus