Innova Solutions is immediately hiring for a CTM/Sr. CTM
Position type: Full time
As a CTM/Sr. CTM you will:
We are seeking an exceptionally talented and driven individual for the Clinical Trial Manager/(Senior) Clinical Trial Manager position. This role will be responsible for providing operational execution, leadership and support for studies conducted by the team, and work in partnership with internal colleagues, external partners, and investigators and clinical site staff to ensure delivery of high quality clinical studies in a timely manner.
ROLE AND RESPONSIBILITIES:
- Responsible for clinical study execution and oversight of all operational aspects Contribute to the identification and selection of appropriate CROs and third-party study vendors Ensure the quality of clinical data meets standards for regulatory submission, publications, and other high-profile business activities. Oversee performance of CROs and vendors to ensure study execution Ensure study team members vendor training on study documents Manage the development of clinical protocols, amendments, informed consent forms, study plans and any other clinical research related documents, in collaboration with cross-functional team members or CRO-partner Organize and run study team meetings on a regular basis to ensure clear and current communication, escalation of potential issues to the appropriate functional leads and team based problem solving and risk mitigation of any arising roadblocks Establish and maintain excellent working relationships with investigators and study staff Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP guidelines and study specific manuals and procedures Participate in feasibility process for finding and selecting new study sites Review and comment on CRFs and database build to ensure integration of all critical aspects of the clinical study being reflected in the clinical database Collaborate with Data Management to oversee data quality issues (query and data quality management and resolution Guide, in conjunction with the CRA lead, the monitoring activity of CRAs and timely execution of data clean efforts to ensure timely data entry and continuous data quality improvements Review key study quality metrics (e.g. eligibility primary endpoint data etc.) and determine appropriate action in conjunction with study team
EDUCATION, EXPERIENCE AND QUALIFICATION REQUIREMENTS:
- BS/BA in the life sciences or in a related field; an advanced degree (eg, MS, PharmD, or PhD) is preferred 5-7 years of experience in clinical operations in the biotechnology or pharmaceutical; experience in oncology highly desirable. Experience with internal model (non-CRO) a bonus Experience with clinical systems including various EDC, IRT, TMF, CTMS, etc. Strong organizational, written and verbal communication skills Willingness to travel up to 30% of the time Permitted to work in the United States
CORE COMPETENCIES, KNOWLEDGE AND SKILL REQUIREMENTS:
- A self-starter who can take on building the operational backbone for early phase clinical studies Experienced in leading international Phase I-III clinical trials Participation in large multi-center and/or global trials, investigational site and CRO management, data collection study protocol compliance Solid understanding of US and global regulations and guidelines (FDA, EMA, ICH) Experience in working in a highly matrix environment and ability to execute in the context of internal and external (vendor) cross-functional teams Desire to learn and grow in terms of scientific knowledge, managerial capabilities and personal development Willingness to take a hands-on approach Ability to work under pressure and aggressive timelines Ability to manage multiple competing priorities, being able to rapidly gather, assimilate and disseminate information on critical project components and milestones Detail oriented with ability to manage technical/scientific aspects as well as operational components of logistics, timing and quality
The ideal candidate will have 5-7 years of clinical operations experience
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.
PAY RANGE AND BENEFITS:
Pay Range*: $130,000-$170,000
*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.
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.
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 email@example.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.