Clinical Scientist - FSP

Remote, United States

Primary Location: United States, Remote

Job ID R0000035205

Category Clinical Trials

ABOUT THIS ROLE

Parexel FSP is seeking a Clinical Scientist with experience in Real World Evidence to join our team!

Job Summary

The Clinical Scientist (CS) will provide of observational study execution including epidemiological, non-interventional, pragmatic and low-interventional studies and research collaborations to ensure consistency of approach, conduct, monitoring, analysis, reporting, and oversight of core team activities within one or more asset programs in the Therapeutic Area (TA).
In collaboration with cross functional colleagues, the CS is responsible for execution and project management of their studies as well as oversight of studies executed by CSs supporting the product. The CS collaborates with other sponsor groups and oversees vendors to execute the studies. The CS is responsible for numerous observational and epidemiological studies run as Company-sponsored and/or as non-Company sponsored Research Collaborations.
The CS has a significant role in partnership with Medical Evidence Generation (MEG), Medical Affairs, Statistics, Clinical Data Sciences, Statistical Data Sciences & Analytics, and external team members, where applicable, and other team members on development of operational plans and provides input on tactical implementation of studies to support the asset strategies in line with Sponsor SOPs. As co-lead of the Study Core Team, the CS leads via a matrix organization to execute studies.

Responsibilities

Responsible for supporting complex or leading low complexity studies across various SOPs, including tasks related to: 1) protocol and protocol specific training, 2) vendor management, 3) study level planning and oversight, 4) data review, 5) regulatory document, study report and publication preparation and review, and 6) overall study execution with a critical focus on consistency, quality, data integrity, safety, and alignment with company processes.
Works in a global environment on studies across all regions including International, Emerging Markets and China.
May represent line in program-wide functions and governance as needed. Contributes to discussions to ensure consistency across products/TA.
Using knowledge of epidemiologic/observational and specific aspects of trials, provides support of operational strategic partner involvement at a program or study level. Identifies issues in a timely manner, leads implementation of solutions, and/or escalates as appropriate.
Provides operational input on tactical implementation of studies.

Basic Qualifications:

Training and Education

BA/BS Degree in life sciences or health related field with 5+ years practical experience or MS/MBA with 3+ years, PharmD/PhD 2 years, MD/DO with 1 year

Prior Experience and Capabilities

Industry experience in the Clinical Scientist role or similar capacity.
Experience working on multinational teams/studies
Hands-on experience in epidemiology study design, conduct and analysis.
Experience in or leading study teams
Experience working independently and collaborating with multiple functional groups within and outside the business line
Demonstrated an ability working across multiple studies for incorporation of consistent medical/scientific concepts in multiple protocols
Strong knowledge of the clinical research process and Good Clinical Practices (GCPs), monitoring, clinical and regulatory operations
Demonstrated independent authorship of study protocols and other study documents
Working knowledge of statistics, data analysis, and data interpretation
Experienced in managing external vendors for clinical and/or epidemiological study (ies).

Skills

Fluent in English writing, reading, and speaking and has exceptional written and oral communication and cross-functional collaborative skills.

Preferred qualifications

Has experience in working in a global setting
Is proficient in MS Word, Excel, and PowerPoint
Prior therapeutic area experience

#LI-REMOTE

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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