Clinical Scientist -First Shift - Randstad USA

job summary:

Seeking a clinical scientist to join the Clinical Development team in hematology/oncology drug development. You will be responsible for supporting senior Clinical Development staff in formulating and executing the Global Development Plan (GDP) for the assigned molecule(s)/indication(s). Responsibilities will include supporting data management and data cleaning activities of hematology/oncology studies, supporting the medical monitor in routine trial activities and oversight for hematology/oncology studies, supporting regulatory submissions, and/or representing clinical development in multidisciplinary teams within Research and Development (R&D).

 
location: Telecommute
job type: Contract
salary: $85.00 - 88.78 per hour
work hours: 9 to 5
education: Doctorate
 
responsibilities:

- Review clinical study data; identify and evaluate study data trends, outliers, and protocol deviations; work with data management to issue and resolve queries to ensure data quality

- Contribute to clinical study reports, including reviewing and interpreting safety and efficacy data

- Participate in the cross-functional team meetings and address study or other program-specific questions

- Support execution and implementation of the Global Development Plan by providing strategic clinical science support for assigned studies and programs

- Contribute to or prepare clinical sections of relevant regulatory filings and meeting packages (INDs, meeting requests, NDAs, etc.)

- Work closely with other functional areas within R&D (clinical operations, data management, biostatistics, clinical pharmacology, nonclinical) to facilitate the execution of clinical trials and ensure high standards of study conduct are met

- Prepare clinical data and clinical program presentations

- Assist in reviewing and authoring study concept documents and clinical study protocols

- Write protocol summaries, process documents, investigator brochures, etc., in collaboration with cross-functional groups

- Provide input on clinical presentation slides for internal/external meetings and communications (e.g., investigator meetings, pre-study site selection visits, site training, study newsletters, communication to sites, etc.)

- Read and interpret scientific and medical literature for use in clinical documents and to assist clinical team decision-making

 
qualifications:

Required Knowledge, Skills, and Abilities

- Excellent oral and written communication skills

- Proven ability to work independently and as part of a multidisciplinary team

- Collaborative and flexible in personal interactions with high emotional intelligence

- 2+ years of clinical/scientific research experience required, with solid tumor oncology expertise preferred

- 2+ years of experience working in a pharma/biotech company or postdoctoral or principle investigator experience within an academic or government setting

Required/Preferred Education and Licenses

- PhD, MD, DO, PharmD, or other advanced scientific or clinical degree

 
skills: Clinical research, Pharmacology, Clinical Data Management, Biostatistical Analysis

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 HRsupport@randstadusa.com.

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).

This posting is open for thirty (30) days.