Clinical Research Manager

Job ID: CRM2018

Location: San Diego, California, USA


Job Description

Based in San Diego, CA, Biological Dynamics, Inc. (BioDyn) is a privately held molecular diagnostics company and a pioneer in the field of Alternating Current Electrokinetics (ACE)-based diagnostics.  At BioDyn, we are developing novel diagnostic solutions to screen, diagnose and manage high burden conditions, such as cancer. Our diverse team shares a passion for improving patient care, a focus on cutting-edge technology, and a deep commitment to innovation, which shapes the future of our company and drives our innovative culture. To learn more about BioDyn, please visit our website, www.BiologicalDynamics.com, or feel free to view a TEDx Talk given by BioDyn’s Co-founder and CEO, Dr. Raj Krishnan, at https://www.youtube.com/watch?v=wMsOYqJ4ShA.

As part of our company’s commitment to developing and delivering to the market a suite of high-performance products, we have an opening for a Clinical Research Manager, on a full-time basis.  The individual in this key role will have primary responsibility for the design, set-up, maintenance, and close out of all of the company’s clinical studies and trials.  As well, s/he will work with other members of staff to manage databases of clinical trial-related information and inventories of clinical samples.  As a team member within this small but growing company, the individual will have an opportunity to make a major contribution to the successful development and commercialization of a novel technology.  This is a great opportunity for an experienced Sr. Clinical Research Associate ready for advancement and increased responsibility and independence.

 

 


Responsibilities

·        Manage all partnerships with the company’s external clinical sites, including communicating and meeting with staff at the sites on a regular and an ad hoc basis;

·        Use knowledge of clinical trial inclusion and exclusion criteria in order to design successful clinical trials and studies;

·        Coordinate logistics on sample transportation and handling;

·        Manage databases of clinical information, and partner on sample accessioning and tracking;

·        Partner with other members of the Team on managing interactions with external CROs;

·        Contribute to defining project scope, budgets, and timelines, and monitor ongoing activities to ensure that efforts are successful and within budget;

·        Ensure that projects comply with all relevant SOPs, regulations, and quality standards;

·        Report on progress and issues with clinical trials and studies on a regular and/or as-needed basis;

·        Contribute to process improvements in all areas related to clinical trials and studies; and

·        Other duties as assigned.


Skills and Qualifications

·        Bachelor’s degree or equivalent in the Health Sciences or Biological Sciences;

·        2 to 5 years of experience managing clinical trials, at a clinical site, sponsor institution or CRO, highly desirable;

·        Direct experience with IVDs or medical devices highly preferred;

·        Experience in handling datasets for clinical studies, with direct knowledge of databases highly preferred;

·        Knowledge of cancer biology and/or therapeutics is a plus;

·        Ability to generate reports, present within the organization, and make external presentations preferred;

·        Strong verbal and written communication skills;

·        Willingness to travel to clinical sites, both locally and elsewhere in the US, as needed; and

·        Ability to exercise discretion with regard to the confidentiality of patient information, per HIPAA and other guidelines.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the individual may be required to sit; use hands to touch, handle, or feel and reach with hands and arms. As well, s/he may occasionally be required to stand and/or move about the office or an event. Specific vision abilities may be required by this job including close vision and ability to adjust focus.  Variable requirement for travel not to exceed 25% on a regular basis.

The successful candidate will join a dynamic, innovative team focused on developing cutting edge technologies in a fast-paced, collaborative environment. Biological Dynamics is an equal opportunity employer. We offer competitive compensation and benefits as well as a positive, diverse and exciting work environment.  To apply for this position please email your cover letter and resume to Biodyn.hr@biologicaldynamics.com.

 


To apply please send your resume and cover letter to biodyn.hr@biologicaldynamics.com.


Biological Dynamics is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.