Clinical Trials Management Associate - II
Clinical Trials Management Associate - II
Posted on :
02-12-2024
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1 Vacancy
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Job Description
Description:
FUNCTION: Clinical Operations Biomarker and Bioanalytical Operations
POSITION OVERVIEW:
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 highquality clinical data that supports global registration and commercialization of Gilead s products.
You will support other Clinical Operations team members in the startup maintenance and closeout 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 investigatorsponsored 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 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
Serves as the point of contact with internal and external stakeholders for successful implementation of all biological sample analysis strategy in Gilead (GS) and Collaborative (CO) programs
Participates in and manages project meetings and conference calls with CROs other vendors and crossfunctional 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 KickOff 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.
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 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 startup to closeout 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 teamoriented highlymatrixed environment.
Ability to execute multiple tasks as assigned.
When needed ability to travel.
POSITION OVERVIEW:
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 highquality clinical data that supports global registration and commercialization of Gilead s products.
You will support other Clinical Operations team members in the startup maintenance and closeout 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 investigatorsponsored 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 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
Serves as the point of contact with internal and external stakeholders for successful implementation of all biological sample analysis strategy in Gilead (GS) and Collaborative (CO) programs
Participates in and manages project meetings and conference calls with CROs other vendors and crossfunctional 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 KickOff 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.
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 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 startup to closeout 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 teamoriented highlymatrixed environment.
Ability to execute multiple tasks as assigned.
When needed ability to travel.
Additional Details
- Managers Requested Bill Rate : (No Value)
- Onsite Offsite : Onsite
Employment Type
Full Time
Key Skills
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