Senior Clinical Trials Management Associate

Proclinical is advertising a vacancy for a Senior Clinical Trials Management Associate position with a leading pharmaceutical research company. The organization prides itself on its solid commercial portfolio of life-saving drugs within a number of therapy areas, along with a growing pipeline of investigational drugs and an unmatched patient access program. Based in the company's California office, this is an exciting opportunity to work with an internationally renowned company and support their innovative impact on the healthcare field.

Job Responsibilities:

• Serving as the key biomarker operational contact with internal and external stakeholders, for successful implementation of biomarker strategy in company and collaborative (CO) programs.
• Participating in multiple Phase 1-3 teams to manage biomarker implementation in clinical trials.
• Planning and coordinating all operational activities required with the collection, delivery, and analysis of biomarker samples within a clinical trial.
• Providing sample management expertise to the Study Management Teams (SMTs).
• Ensuring biomarker samples collected are of good analyzable quality and are collected in adherence to the highest standards of ethics and informed consent.
• Collaborating with biomarker biology to translate sample processing and handling instructions from research setting to the clinical setting.
• Acting as the primary interface for operational activities between the SMT and biomarker laboratory vendors; providing the day-to-day operational management of biomarker vendors to ensure delivery against contracted scope of work.
• Participating in or managing project meetings and conference calls with CROs, vendors, and multi-functional teams.
• Anticipating obstacles and proactively developing solutions to achieve project goals
• Developing a general understanding of functional issues and routine project goals from an organizational perspective.
• Participating oral presentations as applicable.
• Interacting and cooperating with individuals in other functional areas to address routine study issues.
• Developing tools and processes that increase measured efficiencies of the project.
• Assisting in training for Clinical Trials Management Associates (CTMAs) and Clinical Project Assistants (CPAs).
• Assisting in selecting Contract Research Organizations (CROs) or vendors as needed.
• Assisting with the setting and updating of study timelines.
• Participating in departmental, or interdepartmental, strategic initiatives under general supervision
• Conducting vendor visits and providing site training as needed under general oversight.
• Ensuring that the site complies with the protocol and regulatory requirements for GS studies.
• Reviewing protocols, informed consents, and relevant study documents.
• Travel may be required.

Skills and Requirements:

• A BS or BA in a relevant scientific discipline (Clinical Operations and/or Sample Management).
• At least 3 years of experience and an RN (2 or 3-year certificate).
• At least 3 years of experience in the pharmaceutical industry or as a clinical trial coordinator within a clinical trial setting.
• Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples is a plus.
• Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies.
• A strong track record of performing visits to sites according to the Clinical Monitoring Plan.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Allison Stevens at a.stevens@Proclinical.com or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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