Job type full-time
Full job description
Gilead sciences is continuing to hire for all open rolesOur interview process may be conducted virtually and some roles will be asked to temporarily work from homeOver the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.
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Job description
Clinical operations: clinical operations is responsible for the execution of all phase 1-4 clinical trials, across all therapeutic areas, around the worldIn partnership with clinical research, medical affairs and development operations functions, ensures that all clinical trial activities are performed in accordance with all applicable sops, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of gilead’s products.
Clinical trials manager, clinical operations – oncology (ctm)
We are seeking a talented, experienced, and highly motivated candidate to join the oncology clinical operations team.
** this position can be located in foster city, ca, morris plains, nj, seattle, wa or remotely in the usStrong preference to be office based.
Specific responsibilities and skills for position:
Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports
Must be able to understand, interpret and explain protocol requirements to others
Maintains study timelines
Coordinates review of data listings and preparation of interim/final clinical study reports
Assists in determining the activities to support a project’s priorities within functional area
Contributes to development of rfps and participates in selection of cros/vendors
May be asked to train cros, vendors, investigators and study coordinators on study requirements
Contributes to development of study budget
May serve as a resource for others within the company for clinical trials management expertise
Able to examine functional issues from an organizational perspective
Participates in the recruiting and hiring process for cpa/ctma/srCtma and support their professional development
May contribute to development of abstracts, presentations and manuscripts
Under supervision, may design scientific communications within the company
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
Travel may be required
Knowledge:
Excellent teamwork, communication, decision-making and organizational skills are required
Thorough knowledge of fda and/or ema regulations (or relevant local regulations), ich guidelines, and gcp governing the conduct of clinical studies
Working knowledge and experience with word, powerpoint and excel
Experience and skills:
At least 5+ years of experience and a rn (2 or 3 year certificate) or bs/ba in a relevant scientific discipline
At least 3+ years of experience and a masters` degree or higher; scientific discipline preferred
Prior oncology clinical trials experience is preferred
For colorado job applicants: the salary range for this position is:
$115,600.00 – $173,400.00
Gilead considers a range of factors, including background and experience, when determining base compensationThese considerations means actual compensation will vary.
Position is also eligible for bonus and benefitsFor more information, visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing
For jobs in the united states:
As an equal opportunity employer, gilead sciences incIs committed to a diverse workforceEmployment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local lawsIn order to ensure reasonable accommodation for individuals protected by section 503 of the rehabilitation act of 1973, the vietnam era veterans` readjustment act of 1974, and title i of the americans with disabilities act of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, gilead has made the decision to require all u.sEmployees and contractors to receive the covid-19 vaccines as a condition of employment“full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administeredAnyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
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Posted 30+ days ago