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location: Telecommute
job type: Contract
salary: $100 - 110 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
The Clinical Trial Manager provides clinical trial oversight to the assigned clinical trial(s) ensuring deliverables are met in terms of quality, compliance and timing. Strong vendor management is critical for this role. This position will work with internal team members, sites, external vendors and CROs. The position reports to the Director, Clinical Operations and is accountable to the Clinical Operations Lead for assigned studies. This role may work collaboratively on one trial or across several trials to support clinical operations activities.
- Day to day management of assigned clinical trial(s) to ensure deliverables are met in all phases of trial
- Communication to internal team members on deliverables and ensuring timelines are met
- Manage trial feasibility process
- Work closely with study Clinical Operations Lead and/or assigned Clinical Trial Manager(s) to execute clinical studies
- Drafting site materials including training, manuals and support documentation
- Monitoring of clinical data to ensure timely entry and readiness for data review meetings
- Periodic review of clinical data
- Review of clinical monitoring reports to ensure timely completion and identification of issues
- Ensure trial samples are ready to be sent to vendors in order to meet trial deliverables
- Maintain trial metrics
- Ensure trial is conducted in accordance with the company and ICH/GCP standards including multiple regions in global trials
- Support testing clinical trial systems/databases (i.e. UAT)
- May support additional clinical trial(s) in an unblinded Clinical Trial Manager capacity
- Develop and maintain strong, collaborative relationships with key stakeholders within the company
qualifications:
- At least 5 five years of trial coordination experience in a clinical research and industry environment
- Advanced degree preferred or Bachelor's in a science-based subject
- Relevant experience in global setting
- Solid understanding of drug development
- Good project management skills
- Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
- Excellent verbal and written communication skills
- Good organizational skills and attention to detail
skills: GCP (Good Clinical Practice), Drug Safety, ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
