Clinical Scientist

Spectraforce

Cambridge, Massachusetts


21 days ago

Remote

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Job Description

Job Title: Clinical Scientist
Duration: 1 year

Location: Remote
 
Work Schedule  
M-F 8-5 PM EST 

HM Notes:
  • Fully Remote position, Candidate must be able to work EST hours M-F 8AM- 5PM 10% will be required for clinical site management, this is clustered travel
  • Must have: Ophthalmology/retina experience is required
  • A minimum of 3 years of clinical research and clinical drug development experience within the ophthalmology/retina pharmaceutical industry or CRO is required
  • Knowledge in ICH - GCP (Good Clinical Practices) (International Conference on Harmonization).
  • Ph.D., or similar; bachelor’s or master's degree considered for candidates with experience.
  • Degree in Bio Sciences/ Pharmacology
  • Fluent in English
  • Nice to Have: Statistical, data management, and regulatory knowledge.

Description:
  • The primary purpose of the Clinical Scientist’s position is to assist/support the Clinical Research Director (CRD) in the medical/scientific contribution for the clinical studies on activities pertaining to the Study Medical Manager responsibilities e.g.: managing or contributing to the operational activities from clinical trial set-up to clinical study report in compliance with quality and regulatory processes.
  • The clinical scientist will be a responsible member of a clinical team dedicated to the development and execution of clinical strategies and the clinical and operational implementation of a complex compound program. This individual will provide active scientific contribution to a cross-functional clinical team developing a molecular entity, provide input to the clinical development plan, work on the development of the clinical trial protocol, and clinical trial materials, and take responsibility for coordinating the completion of clinical study reports and support preparation of relevant documents for regulatory filings. This role will involve extensive team matrix interactions with colleagues from a number of different disciplines with particular collaboration with clinical operations. This individual may be asked to contribute to the evaluation of scientific opportunities in the therapeutic area.
  • Under the guidance of the individual's manager in the Therapeutic Area department, the individual collaborates with the Coding specialist, Biostatisticians, Data Managers, Global and Regional Study Managers, Feasibility Managers, Pharmacovigilance representative, Medical Writer (e.g. planning and review of narratives) on high quality medical scientific documents, as needed. The individual ensures appropriate review and consistency of the data and investigations of safety cases with the Clinical Trial Team (Monitoring Teams) or Pharmacovigilance.
Skills Required:
• Ophthalmology/retina clinical development and clinical operations experience required
• Scientific expertise or interest and ability to learn in the domain of assigned study/project.
• Well organized, high level of autonomy and motivation,
• Leadership to give directions and organize the activities on behalf of the CRD
• Quality focused, able to develop good practices, using a critical data-driven and risk management approach
• Familiar with digital tools such as data analytics or agility to use them
• Good communication skills (verbal and written)
• Multiple tasks handling and prioritization
• Ability to synthesize the information, good presentation skills
• Ability to work autonomously and to efficiently provide status reports
• Ability to anticipate and timely escalate issues and to execute action plans
• Team and results oriented
• Experience of working internationally with Strong English skills (verbal and written if English is not the native language)
• This position may require approximately 10% travel (within the US)

Note: The Company is committed to complying with the California Consumer Privacy Act (“CCPA”) effective January 1, 2020; and all data privacy and laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAhr@spectraforce.com.  

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $80.00/hr.