Clinical Trials Manager at American Cybersystems, Inc. in San Mateo, California

Job Description:

Innova Solutions is immediately hiring for a Clinical Trial Manager
Position type: Full time Contract.

Duration: 6 months

Location:
Foster City, CA (Hybrid)


As a
Clinical Trial Manager
, you will:

Job Description:


FUNCTION: Clinical Operations - Biomarker and Bioanalytical Operations

Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all client's therapeutic areas.
Clinical Operations plays a key role in ensuring all Client clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of client's products.
You will work with and collaborate with Clinical Operations, Biomarker Sciences, Clinical Pharmacology and other cross-functional team members.
You will manage certain components of clinical studies and act as a member of the study team. You will also manage biomarker and bioanalytical vendors.
You will assist in the review of clinical study protocols and other study documents, contribute to process development and/or participate in special projects. You may also participate in strategic initiatives.

EXAMPLE RESPONSIBILITIES:

Serves as the key biomarker and bioanalytical operational (BBOps) contact with internal and external stakeholders, for successful implementation of biomarker and bioanalytical strategies in client (GS) and Collaborative (CO) programs.
Participate in multiple Phase 1-4 clinical study teams.
Plans and coordinates all operational activities required with the collection, delivery and analysis of biological specimens within a clinical trial.
Provides sample management expertise to the Study Management Teams (SMTs), Biomarker SubTeams (BSTs), and Clinical Pharmacology Subteams (CPST)
Accountable for ensuring biological samples collected are of good analyzable quality and are collected in adherence to the highest standards of ethics and informed consent.
Primary interface for operational activities between the SMT and laboratory vendors; Provides the day-to-day operational management of vendors to ensure delivery data against contracted scope of work.
Has ability to critically evaluate scientific proposal or protocol, and budget for clinical operation feasibility.
Establishes strong cross-functional relationships and exhibits strong leadership skills with counterparts in other functional teams (e.g., Biomarker Sciences, Vendor Outsourcing, Clinical Operations, and Data Management) to ensure efficient execution of the study biomarker strategy.
Proactively identifies potential operational challenges and in collaboration with senior team members provides resolution plans to ensure biomarker strategy remains on track.
Organizes and leads Biomarker and Bioanalytical operational meetings with study functional groups or vendors.
Maintains internal Biomarker and Bioanalytical Operations databases and document repositories.
Review of relevant documents including protocols, informed consents, and relevant study documents
Must be able to understand, interpret and explain protocol requirements to others.
Assists in determining the activities to support a project's priorities within functional area.
Contributes to development of RFPs and participates in selection of CROs/vendors.
Able to examine functional issues from an organizational perspective.
May contribute or participate in special projects.
Develops tools and processes that optimize project efficiencies and effectiveness.
May contribute to development of abstracts, presentations and manuscripts.
Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.
Must have a general, functional expertise to support Process development and implementation.
Provides knowledge and expertise on country specific regulations.
Participates in and manages project meetings and conference calls with vendors and cross-functional teams.
Develops tools and processes that optimize project efficiencies and effectiveness.
Provides input into study protocols and case report forms, authors informed consents, study plans, and presentations.
May be required to present at internal or external meetings (i.e., investigator meetings).
Leads or otherwise assists in the preparation of interim and final study reports, including resolving any data discrepancies when biomarker data is needed for primary, secondary or support.
Proactively identifies potential operational challenges and collaborates with other Clinical Operations' colleagues to provide solutions to ensure study execution remains on track to defined protocols, budgets and timelines.
Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience

PharmD / PhD with 2+ years' relevant clinical or related experience in life sciences.
MA / MS with 3+ years' relevant clinical or related experience in life sciences.
BA / BS / RN with 5+ years' relevant clinical or related experience in life sciences.

Knowledge & Other Requirements

Demonstrated ability to be a fast learner.
Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
Ability to manage any component of full cycle study management, from start-up to close-out.
Advanced knowledge of study management best practices and tools and has shown ability to apply these to improve study efficiencies and effectiveness.
Fully understands protocol requirements and effectively articulates and interprets these. Thorough knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies.
Familiar with standard medical / scientific terminology.
Experience managing the work of external vendors.
Ability to communicate in a clear and concise manner.
Ability to support a team-oriented, highly matrixed environment.
Ability to execute multiple tasks as assigned.


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!

Namrata Gautam
Senior Associate Recruitment
PHONE: (+1) 314-523-1818
EMAIL: Namrata.Gautam@innovasolutions.com

PAY RANGE AND BENEFITS:

Pay Range*: $80- $90 per hour.
*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 centres 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. Apply Now