Job Title: Clinical Data Associate Location: 100% Remote or Santa Monica, CA Duration: 6+ Months
About Role:
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’s 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: Report Authoring:
PMRs: pre-populate tables (including deviation tables) and graphs.
Control Limits: Manage and prepare data, compute and propose statistical limits and assist with report authoring.
Report Verification:
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.
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.
Control limits: verify analytics approaches uses, re-run all analysis, verify updated limits.
Tier 4 Meetings:
Take minutes
Cross-site comparison prep: prepare data, generate outputs from JMP scripts and update the slide deck.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $30.00/daily.
