Participate in the design and execution of global studies for regulatory submissions, reimbursement and product adoption, including clinical study documents (protocol, case report forms, etc.), study implementation and data management.
Manage study preparation, activation, enrollment, submission, maintenance and closure activities.
Participate in administrative activities associated with the clinical department including procedures, training of key personnel and preparation and maintenance of objectives and budgets.
Interface with representatives from key functional groups to drive product development within core teams, and clinical wide or cross-departmental initiatives.
Ensures appropriate oversight of clinical study by internal and external resources including, but not limited to monitoring staff, CROs and core laboratories.
Manage key study investigators; foster and maintain strong relationships through direct interactions with medical advisors and clinical leaders.
Negotiate contracts with hospitals, consultants, investigators, CROs, database management firms and outside suppliers.
Supervise training of investigators, site staff and field clinical staff.
Evaluates clinical and adverse event data during the conduct of the study and for completion of clinical study reports and other technical documents.
Ensures quality by maintaining compliance, reviewing device complaints, reviewing audit reports and implementing corrective actions.
Regularly communicates study status to senior management and represents organization to key customers.

Requirements

Bachelor’s Degree in a scientific field of study with a minimum of 5 years’ experience directly supporting clinical research
Working knowledge of Good Clinical Practice (GCP), FDA, ISO and other applicable regulations)
Knowledge of FDA and international regulations and guidelines including, but not limited to, clinical strategy, GCPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance and medical device reporting
ACRP or SOCRA clinical research certification preferred
Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology
Ability to travel up to 25% domestically and internationally
High attention to detail and accuracy
Computer skills (MS Office products, word processing, spreadsheets, etc.)
Finance and budgeting knowledge
Good prioritization and organizational skills
Excellent critical thinking skills
Excellent influencing and negotiation skills
High energy and results-oriented individual who is mature and successful in a business environment
Proactive and “can do” attitude
Works effectively on cross-functional teams
Effective written, verbal and presentation skills with all levels of management and organizations
Operates both as a team and independently, with adaptability to changing requirements
Ability to work in a fast-paced environment, managing multiple priorities

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 10 days 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 study documentsdata managementclinical researchGood Clinical Practice (GCP)FDA regulationsISO regulationsclinical strategymedical device reportingfinance and budgetingmedical terminology

Soft Skills

written communicationoral communicationinterpersonal communicationattention to detailorganizational skillscritical thinkinginfluencing skillsnegotiation skillsadaptabilityteamwork

Certifications

ACRP certificationSOCRA certification