Founded in 1999, Dexcom, Inc. provides continuous glucose monitoring technology to help patients and their clinicians better manage diabetes. Since our inception, we have focused on better outcomes for patients, caregivers, and clinicians by delivering solutions for people with diabetes - while empowering our community to take control of diabetes.
Seeking an experienced Clinical Research manager with medical device industry experience to manage the company’s Clinical Affairs team to ensure execution of company’s clinical study program. Individual must have at a minimum of 5 years experience working as a corporate-based clinical research manager in a mid-large size clinical research department. Scope of responsibilities include working with cross functional teams to design and develop clinical protocols and associated study documentation, provide direction for clinical study and clinical operations to a team of clinical research professionals and analyze/track various aspects and results associated with the management of an industry clinical research department. Must possess technical writing, communication, and site management skills.
A bachelor’s degree in life science or equivalent is required. Strong, professional oral and written communication skills are needed to conduct presentations relevant to target audiences, interact with scientists, and researchers both within the company and at clinical sites.
Manages multiple facets of clinical projects by performing team leading responsibilities for clinical investigator team. Manages Clinical Affairs personnel. Provides clinical direction on Clinical Affairs, Marketing, and R&D teams. Prepares clinical protocols and clinical components of regulatory submissions. Coordinates clinical studies. Reviews and audit clinical studies. Writes clinical study reports. Prepares abstracts/articles for investigators involved in Dexcom’s clinical studies.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Partners with Clinical Affairs management to develop clinical strategy
- Provides direction to ClinAffairs personnel in order to develop clinical study documents associated with Dexcom’s studies.
- Writes/reviews protocols, study reports, and other materials
- Works independently to implement clinical studies.
- Leads in the planning and execution of clinical projects while adhering to budget, scope and schedule requirements.
- Responsible for the execution of a clinical trial or suite of clinical trials from protocol design to the final clinical study report.
- Executes high quality, integrated cross-functional plans for the project/clinical trial.
- Coordinates the activities of functional groups that comprise the clinical department team for the product including, but not limited to: clinical monitoring, data management, statistics, medical writing, medical monitoring, and safety to insure proper conduct and timely completion of all projects.
- Coordinate predatory functions related to investigator meetings and training. Conduct these meetings.
- Implement strategies for enrollment to ensure timely completion of clinical studies, in alignment with department and corporate strategic objectives.
- Review clinical publications. Achieve high level of clinical expertise in various disease entities and procedures involved in studies.
- Applies best practices in the development, initiation, planning, execution, control and closing of projects.
- May be responsible for coordinating efforts for the trial both within the Company and through a variety of vendors.
- Develops and reviews clinical SOPs. Maintains thorough understanding of clinical regulations and standards (including changing regulations). Creates and implements regular process improvements.
- Ensures that the Clinical Affairs management team is kept up-to-date on the project and brought in as needed.
- Flexibility to work on multiple complex projects
- Collaborates effectively with peers and leadership across departments and can professionally interact/build relationships with FDA, IRB, and key opinion leaders
- Provides detailed reporting on study finances
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Must be able to work well independently as well as function in a cross-functional team. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
- Bachelor’s degree (or equivalent), in a science or health-related field; nursing or diabetes experience desirable.
- Minimum 7 years industry experience (clinical/regulatory affairs in medical devicespreferred) with 4 years as a Sr CRA working in a corporate environment.
- Minimum 2 years managing clinical studies and personnel employed or contracted by a medical device manufacturer.
- Professional certification (e.g. ACRP, SoCRA, RAPS) desired plus.
- Experience with mediation and conflict management desired.
The role requirements involve the ability to:
- Read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Write reports, business correspondence, and procedure manuals.
- Effectively present information and professionally respond to technical and complex questions from groups of healthcare professionals, managers, clients, customers, and the general public.
- Effectively interact with international customers and their local customs as needed.
- Speak effectively before groups of customers or employees of the organization.
- Apply negotiation skills.
- Manage multiple, diversified tasks concurrently and to prioritize projects and tasks effectively.