Clinical Trials Management Associate

4 weeks ago

Foster City, United States Rose International Full time

Minimum Education & Experience:

MA/ MS / PharmD / PhD with 2 + years’ relevant clinical or related experience in life sciences.

BA / BS / RN with 4 +years’ relevant clinical or related experience in life sciences.

Experience in managing the work of external vendors.

Meets all requirements for Clinical Trial Management Associate (CTMA) grade 25 position with demonstrable proficiency.

Required Skill Sets:

sample management experience, strong Microsoft skills, excellent communication skills.

Nice to Have Skill Sets:

clinical operations/bioanalytical operations experience, laboratory (bench) experience.

Position Overview:

Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all therapeutic areas. Clinical Operations plays a key role in ensuring all clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of products.

You will support other Clinical Operations team members in the start-up, maintenance, and close-out of clinical studies. You may manage certain components of clinical studies and act as a member of the study team. You may also manage vendors and/or manage investigator-sponsored research. You may assist in the review of clinical study protocols and other study documents, contribute to SOP development and/or participate in special projects.

Example Responsibilities:

Leads or manage components of Phase I, II or III studies.

Assists Biomarker Sciences, Clinical Virology, and/or Clinical Pharmacology in vendor selection and coordinates all interactions and deliverables from vendors.

May assist as operational contact for studies.

Plans and coordinates all operational activities required with the collection, delivery and analysis of biological samples within a clinical trial.

Manages study timelines, including documentation and communications.

Serves as the point of contact with internal and external stakeholders for successful implementation of all biological sample analysis strategy in collaborative (CO) programs.

Participates in and manages project meetings and conference calls with CROs, other vendors and cross-functional teams.

Participates in the functional review of study protocol and other study related documents such as clinical sample management plan, study communication plan, or presentations for Investigator and/or Study Kick-Off meeting.

Participates in the review and approval of main study and optional informed consents, and may review additional study specific informed consents.

Contributes to SOP development and/or participates in special projects.

Develops tools and processes that optimize project efficiencies and effectiveness.

Proactively identifies potential operational challenges and collaborates with key stakeholders to provide solutions to ensure study execution remains on track to projected budgets and timelines.

Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

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 ability to effectively apply this knowledge to achieve targeted study outcomes.

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 in a clear and concise manner.

Ability to support a team-oriented, highly-matrixed environment.

Ability to execute multiple tasks as assigned.

When needed, ability to travel.

  • **Only those lawfully authorized to work in the designated country associated with the position will be considered.**

  • **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**

Benefits:

For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.

California Pay Equity:

For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.

Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).

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