- 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.
skills: Pharmacology, Data Management Plan, GCP (Good Clinical Practice), 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
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).
Applications accepted on ongoing basis until filled.
- Statistical, data management, and regulatory knowledge.
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USA-Scientist III - Cambridge, United States - Randstad USA
Description
job summary: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, clinical trial materials, and take responsibility for coordinating 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.
location: Cambridge, Massachusetts
job type: Contract
salary: $ per hour
work hours: 8 to 4
education: Doctorate
responsibilities:
- 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.
- 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)
qualifications:
Must have:
