Serves as a Clinical Research Leader within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones.
Oversees/executes feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures.
May serve as the primary contact for clinical trial sites (e.g. site management).
Develops clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports).
Ensures applicable trial registration from study initiation through posting of results and support publications as needed.
Manages/oversees ordering, tracking, and accountability of investigational devices and trial materials.
Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
Interfaces, collaborates and oversees Clinical Research Associates (CRAs).
Oversees and supports the development and execution of Investigator agreements and trial payments.
Responsible for clinical data review to prepare data for statistical analyses and publications.
May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need.
Contributes to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated.

Requirements

Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
BS with at least 6 years, MS with at least 5 years, PhD with at least 3 years of relevant experience preferred.
Previous experience in clinical research or equivalent is required.
Experience working well with cross-functional teams is required.
Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).
Clinical/medical background is a plus.
Medical device experience is highly preferred.

Benefits

Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial managementclinical data reviewstudy protocol developmentinformed consent developmentmonitoring plan developmentinvestigator brochure developmentstatistical analysis preparationsite qualification visitssite initiation visitsinterim monitoring visits

Soft Skills

cross-functional team collaborationcommunicationleadershiporganizational skillsinterpersonal skills

Certifications

CCRACCRCCCRPRACCDEGCPISO 14155MDRMEDDEV