Mgr Clinical Biomarkers & Diagnostics - Program & Project Management - Analysts

Comforcehealth; Georgia (VT); Remote; USD 80,000 - 100,000; Full time

Job summary

A leading company in healthcare is hiring an Mgr Clinical Biomarkers & Diagnostics for a full-time remote position. The successful candidate will oversee project management relating to clinical biomarkers across various therapeutic areas, ensuring operational efficiency and alignment with project goals. Candidates with a strong background in clinical research and significant project management experience are encouraged to apply.

Benefits

Medical & pharmacy coverage

401(k)

Dental/vision insurance

Life Insurance

Short term and Long term Disability

Qualifications

• 4+ years in clinical research or biotechnology.
• Experience with biospecimens management and clinical studies required.
• Project management certification is desirable.

Responsibilities

• Manage projects related to biomarker and diagnostics strategies.
• Coordinate operational activities for clinical studies.
• Develop sample collection plans and manage budgets.

Skills

Project Management

Clinical Operations

Problem-Solving

Detail-Oriented

Communication

Education

Doctorate degree

Masters degree

Job description

Mgr Clinical Biomarkers & Diagnostics - Program & Project Management

Job ID: 1000157 Thousand Oaks , California Job Type: Contract Added - 06/04/25

Job Description

Innova Solutions has a client that is immediately hiring for
Mgr Clinical Biomarkers & Diagnostics

Position type: Full Time Contract
Duration: 12 months Contract
Location: Remote

As an Mgr Clinical Biomarkers & Diagnostics.-, you will:
Job Details:
Specific Job Requirements:
The Clinical Biomarker and Diagnostics (CBD) Operations Lead plans and coordinates all project management and operational activities required to operationalize the biomarker and diagnostics strategies for programs in the Rare Disease, Inflammation, Cardio Metabolic therapeutic areas of (General Medicine). He/she ensures continuity and integrity across projects, coordinates assay development and implementation activities and acts as the primary point of contact for CBD operations for projects requiring biomarker and diagnostic activities including collection, delivery and analysis of biomarker and diagnostics biosamples within one or more clinical projects or clinical studies. He/she is also responsible for biomarker and diagnostics sub-team meeting management, dashboards, following up on actions, organizing meetings and tracking biomarker deliverables.
Essential Duties and Job Functions:
• Drives the implementation and execution of the clinical biomarker and diagnostic plans for therapeutic programs in early and late stage clinical development across therapeutic areas
• Accountable for the development of a projects and/or clinical studys biomarker and diagnostics biosample collection, processing and storage strategies and ensuring their logistical feasibility and cost effectiveness
• Accountable for project management and appropriate forecasting and planning of related biomarker analysis and samples management costs within a project(s) or clinical studies
• Accountable for planning and implementing the biomarker and diagnostics biosamples collection within a project(s) or clinical study including definition of the appropriate material, instructions, lab manual development & review, kit development, database set up, etc
• Accountable for ensuring that data received is consistent with collection and assay plan and protocols
• Serves as first point of contact for biomarker and diagnostics biosamples operational questions and issues within a project(s) and coordinates with internal and external partners (e.g., Bio-Sample Management, Clinical Operations, Biomarker and Diagnostic Leads, and CROs)
• Develops a sample reconciliation plan for each sample type including data management for relevant data collection and reporting within studies while also ensuring consistency of reconciliation activities within project(s)
• Provide regular reports on sample tracking to select samples for analysis based on varying criteria
• Reviews study protocols and sample collection ICFs prior to finalization and provides input to ensure the protocol and ICFs enable sample testing according to the Biomarker and Diagnostics plans.
• Participate in site initiation visits to train sites on sample collection
• Project manages the implementation of clinical trial assays at reference labs and centralized testing vendors, ensures delivery of assay/ data results and is a key contact for the assay lab.
• Project manages contracts, budgets and timelines for biomarker/Dx activities within studies to ensure timely completion of biomarker and diagnostic activities.
Preferred Education/Qualifications
• Life Sciences degree (higher qualification e.g. MSc or equivalent preferred).
• Further qualification, e.g. project management certification is desirable.
• Competent in application of standard business procedures (standard operating procedures, International Conference on Harmonization {ICH}, Global Regulations, Ethics and Compliance)
• 4+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment
Must Have Experience, Skills, Knowledge
• Extensive 2+ years Biomarker Operations experience
• Experience with biospecimens management, must know the different types of biomarker samples and specifications for collection and lifecycle
• Extensive clinical development experience of working in teams running clinical studies, must be able to contribute to protocols and ICFs development
• Extensive Project management skills and knowledge of project management tools is a must, prepare to demonstrate during interview
• Critical reasoning skills including the identification and resolution of complex problems
• Detail oriented with the ability to work independently and manage multiple competing priorities
• Excellent planning, organizational and time management skills
• Effective communication skills
Basic Qualifications:
Doctorate degree
OR
Masters degree and 3 years of experience
OR
Bachelors degree and 5 years of experience
OR
Associates degree and 10 years of experience
OR
High school diploma / GED and 12 years of 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.

Suhail Ahmed
Email: [e-mail]
Phone – 678-834-8320

PAY RANGE AND BENEFITS:
Pay Range: $80 - $85 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 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:

• Named One of America’s Best Employers for New Grads by Forbes (2024
• Named One of the Best Companies to Work For by U.S. News & World Report (Private Companies List, 2024-2025)
• One of the Largest IT Staffing Firms in the US – Ranked #3 by Staffing Industry Analysts (SIA, 2024)
• One of the Largest Staffing Firms in the US – Ranked #13 by Staffing Industry Analysts (SIA, 2024; includes Innova Solutions, Volt, & HireGenics)
• Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023)
• One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC, 2024)
• AWS Advanced Tier Services Partner with 100+ certification

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 [e-mail] [phone]. 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

Thank You!
Team Innova Solutions

Job ID: 1000157 Thousand Oaks , California Job Type: Contract Added - 06/04/25

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