Innova Solutions is immediately hiring for a Director, Clinical Operations
Position type: 6+ Month Contract position
Location: REMOTE
Pay Range: $100/HR - $130/HR
Manages Clinical Operations study start up trial activities for one clinical trial
Responsible for overall study project management of a clinical trial(s) including:
Projection and management of study timelines
Creation and management of clinical trial budgets
Ensures timely reporting of study metrics to line and/or executive management
Manages the CRO and any supportive vendors
Leads cross-functional study management teams (SMT); is responsible for the timely setting of agendas, effective conduct of SMT meetings and timely issuance of meeting minutes
Provides input on study-related meetings, including vendor selection, project kick-off, CRO project meetings, functional area-specific meetings, and Investigator meetings
Ensures investigators and site coordinators are appropriately trained for the study, and that documentation in this regard is collected and filed
Ensures proper training of the CRO and supporting vendors on the protocol
Reviews and approves site monitoring visit reports in accordance with the study Monitoring Plan; escalates risk findings according to the Study Plan or Issue Escalation Plan
Monitors CRO performance using standard Key Performance Indicators (KPI) to ensure compliance to Scope of Work; tracks KPIs for site GCP/study compliance and develops corrective action plans as required
Active participant in selection and initiation of site
Provides input for definition of new or revised process development, problem solving, training, etc., as needed
May lead Clinical Operations-specific process improvement or Clinical projects
Mentors and manages junior Clinical Operations staff, as applicable
May attend qualification, initiation, interim monitoring, and close-out visits.
Occasional domestic US travel, up to 20%
Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry, FDA, ICH guidelines and Good Clinical Practices
QUALIFICATIONS
BS/BA degree in related discipline; or, Advanced degree in related discipline
Typically requires a minimum of six (6) years of related experience, contingent on education/training
Minimum three (3) years' experience in study management is preferred, or equivalent experience gathered in a previous clinical trials management role
Autoimmune or Cell therapy experience
Experience as a Clinical Research Associate is preferred
Direct CRO management is preferred
Extensive clinical operations knowledge and cross-functional understanding of clinical trial methodology
Exhibits ability to learn and apply foreign regulations to the clinical trial/research process
Experience developing trial plans (eg., site monitoring, communication, and issue escalation)
Knowledgeable in CRF design, interactive response technology (IRT) systems, and clinical supply logistics
Knowledgeable in Good Clinical Practice requirements and their application to the conduct of clinical studies in the United States and internationally
Organizes and prioritizes numerous tasks and completes them under time constraints
Frequently applies strong analytical, organizational, and communication skills
Working knowledge of MS Office and MS Project
Detail-oriented
Ability to work either independently or in a team environment
Works on assigned problems of complex scope where analysis of situation or multiple factors is required
Exercises judgment within defined procedures and practices to determine appropriate action
Builds productive internal and external working relationships
Candidates must have good communication skills and great attention to detail. Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.
Thank you!
Jeff.shay@innovasolutions.com
PAY RANGE AND BENEFITS:
Pay Range*: $100/HR - $130/HR
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP). ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields. Recent Recognitions:
One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
ClearlyRated® Client Diamond Award Winner (2020)
One of the Largest Certified MBE Companies in the NMSDC Network (2022)
Advanced Tier Services partner with AWS and Gold with MS
Website: https://www.innovasolutions.com/ Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.
