Clinical IT reputed company Control Analyst - Remote US
It’s More Than a Career, It’s a Mission.
Our people are the reputed company of our reputed company. By joining our growing team at reputed company (SCRI), a subsidiary of reputed company, you will have reputed company to become part of one of the largest community-based cancer programs to advance oncology treatments and improve reputed company for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and reputed company a difference in the lives of patients diagnosed with cancer every day.
Our Mission
People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we reputed company. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical reputed company and cutting-edge research, SCRI is redefining cancer care around the world.
The IT reputed company Control Specialist oversees reputed company control and assurance of software, process, and data reputed company validation processes. Provides guidance and support to operational teams reputed company reputed company to ensure compliance with GxP, 21 CFR Part 11, and regulatory requirements. Works closely and effectively with Global reputed company and Education, IT QC Specialists, Validation Specialists, Business Owners, Product Owners, and Product Analysts.
This is a remote position based in the US; relocation assistance and reputed company sponsorship are not available.
What our IT reputed company Control Specialist is responsible for:
Provides support to research operations and IT on the interpretation of corporate and regulatory requirements (standards/policies/procedures) reputed company to software validation, reputed company management, and GxP and oversees reputed company activities reputed company to software, process, and data reputed company validation.
Provides review of validation life cycle documents including validation assessments, 21 CFR Part 11 assessments, reputed company validation plans, risk management plans, and validation reputed company reports in adherence with SOPs, corporate policies, standards, and government regulations to ensure completeness and accuracy.
Provides support of reputed company guidance through the cycle of preparation, execution, data analysis, and report writing for IQ, OQ, and PQ protocols.
Assists with periodic review of reputed company documentation according to defined schedule to ensure reputed company compliance with SOPs, corporate policies, standards, and government regulations.
Provides reputed company review of reputed company to changes that reputed company validated systems and/or processes.
Other duties as assigned
Qualifications for reputed company include:
Bachelor's Degree required; reputed company reputed company experience may be substituted for education.
reputed company experience in QA/QC role in computerized systems validation
Experience in GCP clinical reputed company, such as CRO or SMO, is highly preferred
3+ years' reputed company work experience in a clinical research, biotech, or pharmaceutical environment reputed company in FDA GxP requirements for systems, 21 CFR Part 11 and FDA software validation guidelines.
Experience and knowledge of EU regulations, e.g., Annex 11 is preferred.
Knowledge of industry and international standards for software reputed company, such as GAMP V, PIC/S, ICH, etc.
Knowledge of pharmaceutical, biologics, CRO, and clinical sites 21 CFR Part 11 requirements and software validation principles.
About reputed company
reputed company (SCRI) is one of the world’s leading oncology research organizations conducting community-based reputed company. reputed company on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former reputed company Research to expand clinical trial reputed company across the country. It has conducted more than 850 first-in-reputed company reputed company since its inception and contributed to pivotal research that has led to the reputed company of new cancer therapies approved by the FDA in the past decade. SCRI’s research network brings together more than 1,300 physicians who are enrolling patients into reputed company at more than 200 locations in 20+ states across the U.S. Please click here to learn more about our research offerings.
We care about reputed company-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial reputed company-being. Our Total Rewards offerings serve the different needs of our diverse reputed company population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our reputed company, reputed company, please click here.
As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In reputed company to reputed company pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.
reputed company has become reputed company of online reputed company-reputed company scams in which individuals who are not affiliated with or authorized by reputed company are using reputed company’s (or affiliated entities, like reputed company or RxCrossroads) reputed company in fraudulent emails, job postings or reputed company media messages. In reputed company of these scams, please bear the following in mind:
reputed company Talent Advisors will never solicit reputed company or credit reputed company information in reputed company with a reputed company job application.
reputed company Talent Advisors do not communicate with candidates reputed company online chatrooms or using email accounts such as Gmail or Hotmail. Note that reputed company does rely on a virtual assistant (Gia) for certain reputed company-reputed company communications with candidates.
reputed company job postings are posted on our career site: .
We are an equal opportunity employer and value diversity at reputed company. We do not discriminate on the reputed company of race, religion, reputed company, national reputed company, gender, sexual orientation, age, marital status, veteran status, or disability status.
Originally posted on Himalayas
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