Ref #: 27576

Employment type: Permanent - Full-Time

Location: US-Remote

Posted: 11-Mar-2021

Description

At DOCS, we care about our people and their passion, as they are the key to our success and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career. We have over 4500 employees globally working on novel therapies that deliver real impact to patients in need.

All our team members have the independence to get the job done and support from the experienced leadership team when you need it. If you want a career with a difference, DOCS is the place for you.

DOCS is currently seeking an experienced individual for a home-based Clinical Scientist position. This position requires previous experience in a pharma/CRO setting and strong experience within the clinical development process.

Position Overview:
The Clinical Scientist/Senior Clinical Scientist will play an integral role in facilitating successful and timely initiation and completion of the Company’s clinical development programs. The Clinical Scientist/Senior Clinical Scientist will work directly with members of the Clinical Development group and with Clinical Operations, Clinical Project Managers, Data Management and Biostatistics, Clinical Research Organizations (CROs) and Clinical Investigators to plan, execute and monitor medical aspects of selected clinical trials. The successful candidate will operate in a highly detailed and organized fashion, with the goal of efficiently driving each program through the clinical development process. The Clinical Scientist/Senior Clinical Scientist will have a strong familiarity with good clinical practices, be a highly motivated, hands on, detail oriented individual with the ability to formulate, develop and execute clinical trials and be able to operate in a highly dynamic environment.


Primary Responsibilities:
Create required clinical trial documents including clinical protocols, investigator brochures, DSURs and clinical modules of the IND
Work closely with Clinical Operations to execute the clinical trial with high quality and according to timelines
Perform ongoing review of clinical data, query generation/resolution and data analysis, including review of draft listings to support data cleaning and interpretation
Provide scientific expertise to Clinical Operations by responding to questions or clarifying issues arising during study conduct
Provide internal safety monitoring for clinical trials
Provide medical input for the clinical database build, CRFs, monitoring plan, data management plan, and statistical analysis plan
Develop and maintain relationships with clinical trial investigators and therapeutic area key opinion leaders
Lead review of study data (e.g. Tables, Listings and Figures and emerging bioanalytical data) and development of CSRs, clinical presentations and publications
Support other members of Clinical Development and Regulatory Affairs departments as may be required
Participates as a standing member of multidiscipline Project Teams


Requirements, Knowledge, Skills and Abilities:
Degree in life sciences (RN, PharmD, MD) with clinical research experience and strong hands-on working knowledge of drug development. MD preferred (Board certified in Internal Medicine is a plus)
5+ years’ directly relevant experience in clinical research management with previous experience as a clinical scientist or medical director, including: trial medical monitoring, hands on experience with clinical operations, and experience liaising with clinical trial teams and study investigators
Prior experience with monoclonal antibody biologics clinical development is a plus.
Experience in translational medicine/early phase clinical trials is a plus
Self-starter, highly motived, highly organized and hands on with outstanding attention-to-detail
Able to work independently and prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment
Excellent written and oral communication skills and interpersonal skills
Experience in analysis and interpretation of emerging clinical data, including use of software packages to analyze data (e.g. pivot tables): MS Office Suite, Visio, Graphpad, Spotfire etc


DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.