Clinical Scientist(clinical trial design, protocol authorship)
Tellus Solutions4.1
Remote
Job details
$124 - $125 an hour
Full time | Contract
Benefits
Vision insuranceHealth insurance
Job description

Job Description:
Requirements:

  • Aesthetic experience, and Toxin experience a plus; global {china/Canada/TAI, Japan, EU] experience a plus rather than regional): 5+ years of CS expertise; knowledge of clinical trial design and drug development process; well-versed in protocol preparation; ability to synthesize and make connections across study data
  • Skillful in Literature searching, review, and data summarization, and in preparation of PowerPoint and other presentations.
  • Excellent organizational and communication skills. Demonstrated ability to meet or exceed timelines.
  • Ability to work independently and in team environment within SOP and best practices of AbbV, and also take direction from lead scientific director on program).

A description of services/supplies/activities:
Under the supervision of the TA-Scientific Director and global clin dev lead for MMP, serve as a study lead clinical scientist and also serve as back-up clinical scientist for regional MMP studies (phase 3 programs) including: China/Canada/Taiwan, EU, US, Japan.
As a clinical scientist,

  • Initiate specific sections of protocol; review or author sections of protocols, CSRs, and regulatory documents as requested
  • Support study startup activities by preparation of or review of study-specific language, ICFs, training materials, training videos
  • Perform literature searching in databases and review as requested and summarization of salient information related to program and competitors; serve to be current in knowledge on the drug use in MMP indication
  • Consistent review and data evaluation across studies (sponsor-run, and other studies in indication reported in literature); perform edit checks
  • Perform clinical data review on China/CAN/TAI ongoing study, elevating issues to TA-SD and responding to requests of SPM for queries, etc.
  • May serve as point of contact for managing questions relating to clinical aspects and subjects' eligibility
  • Participate in clinical development and study team meetings and IEST meetings if needed.
  • Participate in preparation of PowerPoint slide presentations and other KOL presentations; as needed, participate in Investigator Meetings
  • Other general activities: utilize scientific and clinical science expertise to support initiation and execution of MMP R&D programs
  • Contract resource will not need to help with publications or strategy – that will be handled by in-house
  • Desired outcomes:
  • Timely and quality completion of protocols, study reports, and regulatory documents to continue to progress toward initiation of phase 3 studies (globally) and completion of such studies meeting corporate milestones
  • Timely and quality contributions to regulatory arguments and submission documents, all while meeting corporate milestones
  • Timely and quality evaluation/review of China/CAN/TAI study data meeting all dates and DBL in Feb 2023
  • Support for KOL and IM presentations – enabling the completion of investigator trainings and timely start of studies/FPS

Job Types: Full-time, Contract

Pay: $124.00 - $125.00 per hour

Benefits:

  • Health insurance
  • Vision insurance

Schedule:

  • 8 hour shift
  • Monday to Friday

Experience:

  • Clinical Trial Design: 1 year (Preferred)
  • Protocol Authorship: 1 year (Preferred)

Work Location: Remote

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Employee

11 to 50

Revenue

$1M to $5M (USD)

Company ratings
  • Overall
    4.1
  • Company & Benefits
    3.8 / 5
  • Culture & Values
    4.2 / 5
  • Career Opportunities
    3.7 / 5
  • Work/Life Balance
    4.3 / 5
  • Senior Management
    4.0 / 5
Company reviews
"Tellus is nice."
Current EmployeeAd Rader
It's a nice company. The work is detailed you should be detailed doing this job. They do have a help center to make sure if you have questions you can get the answers. Nice Company.
Pros:
Cons:

"Flexible but unreliable way to earn money"
Current EmployeeInternet Safety Evaluator
The best part of the job is the flexibility. You decide when you work. The worst part is that work is not always available. Do not intend for this to be your main source of income.
Pros:
Cons:

"Productive and fun"
Former EmployeeSecretary
Productive and fun great food options and also has a great cafeteria but needs work on the food delivery system especially to the offices and the surrand
Pros:

"Typical contract company"
Former EmployeeProduction Worker
They were very helpful with any questions I had during the hiring process and even during the employment were easily accessible for help. No benefits but it is typical for most contracting companies.
Pros:
Cons: