Full Job Description
Innova Solutions has a client that is immediately hiring for a Clinical Data Associate - II
Position type: Full time Contract
Duration: 6 months
Location: Foster City, CA
As a(n) Clinical Data Associate- II you will:
Requirements and Preferred Qualifications:
Project Work:
1. Report Authoring:
a. PMRs: pre-populate tables (including deviation tables) and graphs
b. Control Limits: Manage and prepare data, compute and propose statistical limits and assist with report authoring
2. Report Verification:
a. PMRs: raw data, figure and table formats, re-run all charts, check control limits, tables, statistics summaries and deviations against original data sources and metadata files.
b. APRs: raw data, figure and table formats, re-run all charts, check control limits, tables, statistics summaries and deviations against original data sources and metadata files.
c. Control limits: verify analytics approaches uses, re-run all analysis, verify updated limits.
3. Tier 4 Meetings:
a. Take minutes
b. Cross-site comparison prep: prepare data, generate outputs from JMP scripts and update the slide deck.
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
PHONE: (+1) 314-523-1818
EMAIL: Namrata.Gautam@innovasolutions.com
PAY RANGE AND BENEFITS:
Pay Range*: $32 - $37 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:
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.
''
Position type: Full time Contract
Duration: 6 months
Location: Foster City, CA
As a(n) Clinical Data Associate- II you will:
- Works collaboratively with Process Engineers and Statisticians in Global Manufacturing Sciences and Technology (GMSAT), Statistical Sciences & Analytics (SS&A) team to meet project deliverables and timelines to author and approve Continued Process Verification (CPV) related reports, such as Process Monitoring Reports (PMR) and Annual Product Reviews (APR).
- Performs Data Verification requirements per Client Standard Operating Procedures (SOP), e.g., reproduces all CPV statistical output using JMP scripts, reviews documents for data and information accuracy, notifies author of errors and ensures corrections are made prior to approval and completes sign offs in QMS. Assists with report authoring by populating graphs, tables and attachments in Word templates and identifying deviations using QMS.
- Extracts and transforms data from excel or databases, as needed. Attends and participates in regular meetings to review and track report progress.
- Assists with the preparations for bi-monthly Process Monitoring Tier 4 meetings, attends meetings and takes meeting minutes. Must be able to effectively communicate and possess good problem solving as well as people/project leadership skills.
Requirements and Preferred Qualifications:
- BS degree with 5 years or MS degree with 3 years of technical experience in biologics / biopharma, high-tech industry
- BS or MS degree in Data Analytics, Data Science, Applied Statistics or Applied Math, preferred
- Proficient in SQL, SAS or equivalent for data extraction and transcription
- Proficient in JMP, SAS or equivalent for statistical analyses and familiar with Statistical Quality Control techniques, e.g., SPC and Process Capability.
- Knowledge of python code for report generation.
- Proficient in Microsoft Word and Excel
- Exceptional attention to detail with the ability to meet aggressive deadlines
- Good communication and documentation skills, ability to network and interact with manufacturing sites in different time zones
- Knowledge of data management and ability to manage project and prioritize multiple projects
- Familiarity with a Quality Management System (QMS) and how it is used in biotech
Project Work:
1. Report Authoring:
a. PMRs: pre-populate tables (including deviation tables) and graphs
b. Control Limits: Manage and prepare data, compute and propose statistical limits and assist with report authoring
2. Report Verification:
a. PMRs: raw data, figure and table formats, re-run all charts, check control limits, tables, statistics summaries and deviations against original data sources and metadata files.
b. APRs: raw data, figure and table formats, re-run all charts, check control limits, tables, statistics summaries and deviations against original data sources and metadata files.
c. Control limits: verify analytics approaches uses, re-run all analysis, verify updated limits.
3. Tier 4 Meetings:
a. Take minutes
b. Cross-site comparison prep: prepare data, generate outputs from JMP scripts and update the slide deck.
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
PHONE: (+1) 314-523-1818
EMAIL: Namrata.Gautam@innovasolutions.com
PAY RANGE AND BENEFITS:
Pay Range*: $32 - $37 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+ certifications
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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