With supervision, oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy.
location: Waltham, Massachusetts
job type: Contract
salary: $45 - 52 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Contribute to the review, interpretation and communication of scientific data pertaining to the efficacy and safety of compounds in development. Attends congress and reviews literature to develop and augment expertise in therapeutic area
- Help develop program strategy including the clinical development plan, product lifecycle plans, target product profiles and draft labels. Reviews competitive landscape and help identify and evaluate business development opportunities.
- Responsible for providing focused scientific and clinical study support from start-up clinical study report (CSR).
- Participate in scientific education of internal and external stakeholders on the pre-clinical (e.g. mechanism of action, animal models) and clinical (e.g. epidemiology, diagnosis, treatment) data relevant to program. Engage opinion leader interactions to build pipeline awareness and foster research collaborations.
- Contribute to the scientific content of Study Protocols, Investigator Brochures, Clinical Study Reports, Informed Consent Forms, briefing documents, charters, and regulatory documents.
- Contribute to creation of electronic database, IRT, and associated training documents and review data completeness and fidelity throughout study conduct.
- Collaborate cross-functionally to help create a scientific platform in support of the regulatory, commercial and medical education strategy for late-stage assets.
- Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Contributes to authorship of regulatory responses and may participate in meetings.
qualifications:
Required Qualifications
- Bachelors degree in the sciences; advanced degree (e.g., MS, PhD, PharmD) preferred.
- Experience Level / 3-5 Years
- Ability to provide input and direction to clinical research with appropriate supervision
- Strong desire to collaborate in a cross-functional setting.
- Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols.
- Clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred.
skills: Clinical Development Strategy, Clinical Study Report (CSR), Clinical Trial Protocol Design, Interactive Response Technology (IRT)
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: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
