Scientist III - Cambridge, United States - LHH Recruitment Solutions

LHH Recruitment Solutions Cambridge, United States

1 week ago

Description

Job Description

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.

The primary purpose of the Clinical Scientists 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.

Under the guidance of his/her manager in the Therapeutic Area department, he/she 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. He/she 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)

Pay Details: $86.00 to $88.00 per hour

Search managed by: Lauren Litten

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to

The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.

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