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Clinical Trials Management Associate
2 months ago
About Client:
The client is a leading American biopharmaceutical company.
It specializes in the discovery, development, and commercialization of innovative therapeutics, particularly in antiviral drugs for HIV, hepatitis B, hepatitis C, and influenza.
Known for key products like Truvada, Biktarvy, and Sovaldi, it invests heavily in research and development to address unmet medical needs.
The company also focuses on expanding its portfolio through strategic acquisitions and collaborations, while maintaining a commitment to improving global health and access to medications.
Rate Range:
$60–$62.98/Hr
Job Description:
Clinical Operations is responsible for the worldwide execution of all Phase I – IV clinical trials across all Gilead therapeutic areas.
Clinical Operations plays a key role in ensuring all Gilead 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 Gilead's 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.
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 Gilead 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
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.
Requirement:
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.
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.
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
About ApTask:
ApTask is a leading global provider of workforce solutions and talent acquisition services, dedicated to shaping the future of work.
As an African American–owned and Veteran–certified company, ApTask offers a comprehensive suite of services, including staffing and recruitment solutions, managed services, IT consulting, and project management.
With a focus on excellence, collaboration, and innovation, ApTask provides unparalleled opportunities for professional growth and development.As a member of the ApTask team, you will have the chance to connect businesses with top–tier professionals, optimize workforce performance, and drive success across diverse industries.
Join us at ApTask and be part of our mission to empower organizations to thrive while fostering a diverse and inclusive work environment.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.
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At ApTask, we prioritize safeguarding your privacy.
As part of our recruitment process, certain Personally Identifiable Information (PII) may be requested by our clients for verification and application purposes.
Rest assured, we strictly adhere to confidentiality standards and comply with all relevant data protection laws.Please note that we only collect the necessary information as specified by each client and do not request sensitive details during the initial stages of recruitment.
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