[Remote] Clinical Trials Manager- Oncology at Gilead Sciences

United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, OncologyIndustries

Requirements

5+ years of experience and a BS or BA in a relevant scientific discipline OR 3+ years of experience and a MS in a relevant scientific discipline
Excellent teamwork, communication, decision-making and organizational skills
Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable
Ability to generally understand, interpret, and explain protocol requirements to others
Ability to prioritize multiple tasks
Minimal travel (<10%) may be requested

Responsibilities

Coordinating and supervising all aspects of a clinical study
Monitors clinical trial sites
Assists Clinical Program Manager in overall study management
Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports
Maintains study timelines
Contributes to development of study budget
Contributes to development of RFPs and participate in selection of CROs/vendors
Manage CROs/vendors
Coordinates review of data listings and preparation of interim/final clinical study reports
May contribute to development of abstracts, presentations, and manuscripts
Ensures effectiveness of site budget/contract process
May be asked to train CROs, vendors, investigators, and study coordinators on study requirements
Assists in determining the activities to support a project’s priorities within functional area
Under supervision, may design scientific communications within the company
May serve as a resource for others within the company for clinical trials management expertise
Under general supervision, is able to examine functional issues from an organizational perspective
Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
Must have a general, functional expertise to support SOP development and implementation

Skills

Key technologies and capabilities for this role

Clinical Trials ManagementSite MonitoringStudy ProtocolsInformed ConsentCase Report FormsMonitoring PlansInvestigator BrochuresClinical Study ReportsCRO ManagementVendor ManagementStudy BudgetingRFP DevelopmentOncologyThoracic Oncology

Questions & Answers

Common questions about this position

What is the salary or compensation for the Clinical Trials Manager role?

This information is not specified in the job description.

Is this Clinical Trials Manager position remote or does it require office work?

This information is not specified in the job description.

What key skills are required for the Clinical Trials Manager position?

Excellent teamwork, communication, decision-making, and organizational skills are required, along with thorough knowledge of FDA/EMEA regulations, ICH Guidelines, and GCPs, and the ability to prioritize multiple tasks and understand protocol requirements.

What is the company culture like at Gilead Sciences?

Gilead emphasizes collaboration, determination, and a relentless drive to make a difference, with people leaders driving an inclusive culture where employees feel developed and empowered. Every team member plays a critical role in scientific innovations.

What makes a strong candidate for the Clinical Trials Manager role?

Strong candidates will have experience coordinating clinical studies, managing CROs/vendors, maintaining timelines, and demonstrating excellent teamwork, communication, decision-making, organizational skills, and knowledge of clinical trial regulations.

Gilead Sciences

Develops and commercializes biopharmaceuticals

About Gilead Sciences

Gilead Sciences focuses on discovering, developing, and commercializing medicines for various medical conditions, including HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular issues. The company conducts extensive research and development to create new therapies, which are then marketed to healthcare providers, hospitals, and pharmacies after receiving regulatory approval. Gilead differentiates itself from competitors through its strong commitment to R&D and strategic partnerships, such as with SAP Ariba, to enhance its operations and product offerings. The company's goal is to improve health equity and access to care globally, working with communities to ensure that its medicines reach those in need.

Foster City, CaliforniaHeadquarters

1987Year Founded

$15,873.6MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Paid family time off and paid parental time off

Generous 401(k) contribution matching

Comprehensive medical plans that cover both physical and mental healthcare

Global Wellbeing Reimbursement

Time Off

Global Volunteer Day

Giving Together Program

Employee Support Programs

Flexible Work Options

Risks

Increased competition in HIV treatment from ViiV Healthcare's expanding drug portfolio.

Regulatory scrutiny over drug pricing could impact Gilead's U.S. market operations.

Patent expirations, like Truvada's, lead to increased generic competition and revenue loss.

Differentiation

Gilead's lenacapavir is recognized as the 2024 Breakthrough of the Year for HIV care.

Partnerships with LEO Pharma and Tubulis enhance Gilead's focus on inflammatory and cancer therapies.

Gilead's commitment to health equity initiatives like COMPASS and HepConnect sets it apart.

Upsides

Gilead's strategic partnerships expand its reach in inflammatory and oncology drug markets.

Investment in digital health technologies enhances Gilead's R&D and patient engagement.

Focus on sustainability improves Gilead's operational efficiency and corporate reputation.

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