Contract Clinical Trial Manager-Sr. Clinical Trial Manager
American Cybersystems, Inc.

Job Info

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Innova Solutions is immediately hiring for a Contract Clinical Trial Manager-Sr. Clinical Trial Manager

Position type: Full-time Contract

Duration: 6 - 12 month

Location: Hybrid role in Redwood City, CA - 3 days onsite

As Contract Clinical Trial Manager-Sr. Clinical Trial Manager you will:

Job Description

This is an exciting opportunity to work within a fast-paced environment with a dedicated, passionate, intelligent team. As a Contract Clinical Trial Manager, you will be responsible and accountable for managing operational activities for assigned studies and may assume responsibility for additional vendors, studies and/or clinical programs, as they become available. The Clinical Trial Manager provides operational leadership to ensure the study milestones are delivered on time, within budget, with high quality, and in compliance with the ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs. The Contract Clinical Trial Manager will help establish new processes and work instructions to ensure consistent, effective, and efficient execution of clinical operation activities. The Contract Clinical Trial Manager will partner with key stakeholders (internal and external) to ensure continuous harmonized operations of clinical operations activities and to maintain high standards for performing in a cross-functional environment. The Clinical Trial Manager may also manage junior staff members as well as develop and participate in departmental training and annual review processes.

Essential Responsibilities:

• Support Study Lead and take on responsibility and management of clinical trial to ensure that corporate goals are met, studies are completed on time, within budget, and in compliance with SOPs, FDA/EMA regulations and ICH/GCP guidelines.
• Responsible for study start-up, including working with cross functional teams on startup, and with the CRO on site selection/activation.
• Act as the study lead delegate on cross-functional study teams, Vendor, and CRO operational meetings and ensure compliance with global operational standards and procedures.
• Support vendor selection, onboarding, management, and oversight of multiple vendors including but not limited to CRO (including RFPs and bid defense for CRO and finalization of SOW), imaging, central and specialty labs, eCOA, and compliance.
• Manage vendor operational meetings to ensure project goals and timelines are met.
• Assist with or be responsible for the management of key study parameters (e.g., start-up activities, site feasibility, enrollment, site management, data collection, data review, database lock, etc.) and proactively identify solutions within the clinical team when issues arise.
• Participate in the development and review of study related materials, including but not limited to informed consent forms, case report forms, study manuals and plans, and other supporting clinical trial materials.
• Create study specific tools and manuals to ensure timeliness, standardization, and control of data quality.
• Assist with the analysis and development of action plans to address issues with investigational sites and/or vendors.
• Responsible for the review and oversight of tasks in study management plans for operations and all operational activities associated with clinical trials.
• Review/approve invoices, and ensure timely payment processing for vendors, including investigative sites (as applicable).
• Ensure inspection-readiness for all assigned studies, including ensuring all components of the trial master file (TMF/eTMF) are up to date and accurate.
• Assist with the planning, coordination, and presentation at Investigator Meetings and CRA Training meetings, SIVs, and ad hoc trainings, as requested.

Education/Experience:

• BA required, preferable in a scientific/medical field. Advanced degree preferred.
• 7-10 years of experience in Clinical Operations or related function, working with CROs and other vendors, with increasing responsibility and scope; Oncology experience preferred.
• Early phase and start up experience required.
• Working knowledge of FDA/EMA regulatory requirements and ICH/GCP guidelines
• Previous experience working in cross-functional environment.
• Demonstrated experience in selecting, managing, overseeing, and successfully developing effective relationships with multiple vendors and CROs.
• Proficiency with Microsoft applications
• Prior experience working in a start-up environment is a highly desired.

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!

Preeti Sehgal

preeti.sehgal@innovasolutions.com

PAY RANGE AND BENEFITS:

Pay Range*: $70 - $80/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.

The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

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