Clinical Trial Manager

Innova Solutions is immediately hiring for a Clinical Trial Manager

Position type : Full-time Contract

Duration : 6 months with possibility to extend

Location : Hybrid role in South San Francisco, CA

As a Clinical Trial Manager you will :

The Clinical Trial Manager (CTM) is responsible for the day-to-day oversight of global clinical trials and will manage internal stakeholders, CROs, multiple service providers, clinical monitors, and clinical trial sites.

The CTM will focus on the management and support of multinational, multicenter, Phase II studies and may assume responsibility for additional studies / indications as they become available.

The CTM works closely with and supports the Clinical Development Operations team, receives assignments in the form of objectives, and determines how to use resources to meet schedules and goals.

This position will also work closely with a cross-functional team based in the US and Shanghai to ensure that clinical trials are conducted in a timely fashion and compliant with SOPs, ICH / GCP, Country specific regulatory guidelines, company goals, and budgets.

This role works on issues of diverse scope where the analysis of situation or data requires evaluation of variety of factors including an understanding of current business trends.

The CTM will be responsible for managing various project goals and supporting delivery of a quality study on time and within budget.

RESPONSIBILITIES AND DUTIES

• Leads and coordinates global cross-functional study teams through all study stages (start-up, conduct, close-out).
• In collaboration with internal stakeholders, responsible for helping to drive the RFP and RFI process, analyze service providers, budgets and proposals, conduct bid defense meetings, award services, negotiate and execute complex agreements (i.

e., CRO, study related collaboration agreements).

• Provides oversight and direction to the CRO and service providers providing regional and / or global study services
• Assists with Inspection Readiness activities which may require the development, modification and / or implementation of policies as needed to ensure high quality and integrity in all study activities
• Participates in the development and review of study documents including, but not limited to, CRF design, project plans, Service Provider Oversight plans, TMF plan
• Follows processes and procedures and recommend changes to SOP's and policies to ensure comprehensive and compliant processes in the clinical operations organization
• Identifies potential study issues / risks, escalates as needed and recommends / implements solutions.
• Manages study sites and study related activities including but not limited to site feasibility, selection, start up, subject recruitment, enrollment, study management, monitoring report review, site management, trial master files, and data clean up.
• Prepares or reviews clinical sections of regulatory submission documents, responses to EC and / or Health Authority questions
• Monitors study progress for possible changes in study scope to ensure timely change order implementation and finalization
• May have some responsibility for the oversight and management of the study budget including site and service provider budgets
• Supervises ongoing communication of operational issues and provides accurate progress reports on assigned activities to Study Management Team and Clinical Development Team.
• Ensures oversight of data and information in study specific systems eg. EDC, CTMS, eTMF is current and accurate.
• May lead a cooperative effort on a project team or contribute as a subject matter expert on key projects and initiatives to identify and implement process improvements and standards.
• Other supportive duties as assigned to achieve operational objectives

CORE COMPETENCIES, KNOWLEDGE AND SKILL REQUIREMENTS

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
• In-depth understanding of FDA and EU regulations, ICH Guidelines and GCP requirements governing the conduct of clinical trials.
• Remote based position with occasional travel to the South San Francisco office (flexible)

REQUIREMENTS

Education

Bachelor's degree or equivalent (scientific or healthcare discipline preferred)

Experience

• Minimum of 7 years of related industry experience as a Clinical Research Associate or related function with increasing responsibility and scope
• Minimum of 3 years study management experience in clinical and drug development
• Experience in selecting, managing, and overseeing sites, CROs, specialty labs and other service providers in global, multinational studies or programs
• Experience in supporting SOP development and implementation is desired
• Experience working on global teams is desired, Asia-Pacific and EU highly preferred

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

PAY RANGE AND BENEFITS :

Pay Range* : $80 - $90 / hr depending on exp

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 :

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 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.

Desired Skills and Experience

Experience

7+ years of experience in a biotech or pharmaceutical company, leading cross-functional clinical activities with increasing responsibility and scope

Minimum of 3+ years study management experience in clinical and drug development, including management of studies outsourced to CROs.

Experience in selecting, managing, and overseeing sites, CROs, specialty labs and other service providers in global, multinational studies or programs.

Experience in supporting SOP development and implementation is desired.

Experience working on global teams is desired, Asia-Pacific and EU highly preferred.

American Cybersystems, Inc is acting as an Employment Agency in relation to this vacancy.