"Alerted.org

Duration: 6 months contract

Job Description:

Onsite or remote:** Location **strongly prefer Boston / Waltham** —to enable partnership with the TA MD. If remote has to be in tied with Client Hub – **Chicago (2nd preference)** or **South San Francisco (3rd preference).

+ 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.

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.

Experience:

+ **Experience Level = 3-5 Years**

+ **Oncology clinical trial experience** in the **Oncology (preferably solid tumors)** therapeutic area in the pharmaceutical industry

+ **Hands on experience** with **data review and clean, data analysis with extensive experience using EDC, CTMS and other database.**

+ Knowledge of **clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols**

Skills:

+ **Oncology clinical trial experience** in the **Oncology (preferably solid tumors)** therapeutic area in the pharmaceutical industry

+ **Hands on experience** with **data review and clean, data analysis with extensive experience using EDC, CTMS and other database.**

+ Contribute to the **scientific content of Study Protocols, Investigator Brochures, Clinical Study Reports, Informed Consent Forms, briefing documents, charters, and regulatory documents.**

Education:

+ **Bachelors degree** in the sciences; advanced degree **(e.g., MS, PhD, PharmD)** preferred.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.