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Sr. Clinical Trial Management Associate
3 months ago
Job Title: Sr. Clinical Trial Management Associate (Senior CTMA)
Job Type: 6+ months Contract
Job Location: Foster City, California, USA, 94404
Work Schedule: On-site
Description:
JOB TITLE: Sr. Clinical Trial Management Associate (Senior CTMA)
FUNCTION: Clinical Operations – Biomarker and Bioanalytical Operations
REQUIREMENTS:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Minimum Education & Experience
• MA/ MS / PharmD / PhD with 2 + years’ relevant clinical or related experience in life sciences.
• BA / BS / RN with 4 years of relevant clinical or related experience in life sciences.
• Experience in managing the work of external vendors.
• Meets all requirements for the Clinical Trial Management Associate (CTMA) grade 25 position with demonstrable proficiency.
Knowledge & Other Requirements
• Demonstrated ability to be a fast learner.
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily, and provide support/expertise where needed.
• Knowledge of full cycle clinical study management, from start-up to close-out, and has shown the ability to apply this knowledge to achieve targeted study outcomes effectively.
• Significant industry knowledge.
• Complete knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, Good Clinical Practice (GCP) and key Clinical Operations principles, concepts, practices, standards, processes and tools.
• Familiar with standard medical/scientific terminology.
• Ability to communicate clearly and concisely.
• Ability to support a team-oriented, highly-matrixed environment.
• Ability to execute multiple tasks as assigned.
• When needed, ability to travel.
Top 3 Required Skill Sets: sample management experience, strong Microsoft skills, excellent communication skills
Top 3 Nice to Have Skill Sets: clinical operations/bioanalytical operations experience, laboratory (bench) experience
Unique Selling Point of this role: working with a diverse/cross-functional group
