Clinical Research Scientist
100% Remote (Need to live on East Coast or Midwest)
(Monday-Friday) Flex hours 40 per week
Pay: $86.00 an hour
12 month contract opportunity
Must bachelors degree, 7-10 years of clinical research experience and experience with lupus.
As a subject matter expert, the Clinical Research scientist (CRS) partners with the Medical Director to provide scientific, clinical, strategic, and operational input to an early or late-stage clinical development program. The CRS contributes to data interpretation, study designs, regulatory documents, and publications as well as providing scientific input into pipeline programs. The CRS closely collaborates with other internal functions as well as external partners, such as contract research organizations and medical experts.
Within the frame of the clinical development of new medicines, the Clinical Research Scientist is responsible for
Managing assigned activities within clinical study independently
providing clinical/scientific input and gathering necessary information from other areas to Clinical Development Plans for one or more molecules or indications
Work in close partnership with CROs and other vendors in clinical and medical data review and participating in operational excellence of the execution of the project in collaboration with GCO
Work on the design of Clinical trial concepts, study protocols, assessment schedules, patient information material as well as final clinical study reports
Work on the relevant sections of the common technical document dossier
Help to design and structure the content of relevant Advisory Board Meetings
Writes scientific rationale for clinical trial protocols, including most recent literature citations
Drives creation and annual update of IB liaising with Toxicology, Pharmacology, Safety, Regulatory and Medical & Communication Experts
Works closely with Medical Communications to ensure all relevant documentation is updated with new medical information, including assuming responsibility for the incorporation of additional information into the Investigator Brochure.
The Clinical Research Scientist is an individual contributor with analytical skills, strategic thinking, and a growth mindset.
Ability to work both independently and collaboratively on assigned tasks or projects of increasing complexity with scientific rigor in a fast-paced, team-based matrix environment.
Expert knowledge of scientific principles and concepts
Aptitude to interpret and to integrate data, including, clinical safety and efficacy data, pharmacokinetics, biomarker and next generation sequencing data
Moderate medical or clinical knowledge and experience in clinical development/ operations with the capacity to monitor labs and other clinical data from clinical trials
Experience in product & clinical development (minimum of 3 years, with at least 5 years in a comparable setting in biopharma, preferred)
Capability to perform literature searches and to utilize library services, digest the information, and synthesize the key take-away points
Strong communication skills - verbal, written and listening, with the knack to contribute to abstracts/publications
Record of having completed or significantly contributed to scientific work or project
Strong presentation skills and adapting to a variety of audiences
Normally receives no instruction on routine work and only general instruction on new assignments
Educational and/or work experience in the respective therapeutic area (eg Neurology or Immunology) is strongly desirable.
Experience in analysis and interpretation of clinical data and a working knowledge of biostatistics, ICH-GCP, and regulatory requirements for clinical studies.
Excellent written/verbal communication and presentation skills.
High level of organizational and project management skills.
Experience interacting with development operations (clinical operations, regulatory, QA) and clinical investigators.
Bachelor's Degree required, preferred in Science with a minimum of 7+ (minimum) years of experience in product & clinical development in Clinical Development or 9+ in a comparable setting in the pharmaceutical industry.
MilliporeSigma is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual made a good faith report of discrimination.
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