Address
Form of workThe Director Inspection Readiness and CAPA Management is responsible and accountable for leading, directing, and coordinating Inspection Readiness and CAPA Management activities within Clinical Data Management. They will also contribute to the strategy and implementation of enhanced quality systems and standards within Global Development with partner QA/GCP Compliance functions.
A typical day might include the following:
Drive the vision for Inspection Readiness through proactive internal reviews, providing teams with support to resolve obstacles to process adherence and well detailed training delivered by SMEs and other qualified instructors.
Serves as an internal departmental quality/compliance authority to provide consultative support to study teams with quality/compliance-related questions/concerns and/or those requiring assistance to resolve an historical/ongoing problem.
Support the improvement in quality by proactively identifying and addressing areas of concerns from Health Authority inspection findings to avoid downstream issues.
Responsible for proposing/defining internal DM quality-related metrics as well as ongoing collection and quarterly reporting including inspection-related metrics and governance of HA responses and CAPA fulfillment.
Establish criteria to evaluate the efficiency of corrective actions, and periodically assess the efficiency of training and job aids for new processes or changes to documentation requirements.
Collaborates closely with Global Development functions, to ensure that CAPA fulfilment activities are defined, measured, handled and that takeaways are leveraged to improve efficiency and quality of clinical trial collection, analysis, reporting and submission across studies.
Defines and implements a minimally intrusive internal review approach to identify potential quality problems in ongoing studies and facilitate proactive remediation before minor issues become significant quality risks.
Coordinate with CDM Portfolio Head and CDM CDU Heads to assess the portfolio of ongoing and planned studies to understand the near term, medium-, and longer-term likelihood for future DM-related inspection targets.
Drive the vision for Inspection Readiness through proactive internal reviews, providing teams with support to resolve obstacles to process adherence and well detailed training delivered by SMEs and other qualified instructors.
Serves as an internal departmental quality/compliance authority to provide consultative support to study teams with quality/compliance-related questions/concerns and/or those requiring assistance to resolve an historical/ongoing problem.
Support the improvement in quality by proactively identifying and addressing areas of concerns from Health Authority inspection findings to avoid downstream issues.
Responsible for proposing/defining internal DM quality-related metrics as well as ongoing collection and quarterly reporting including inspection-related metrics and governance of HA responses and CAPA fulfillment.
Establish criteria to evaluate the efficiency of corrective actions, and periodically assess the efficiency of training and job aids for new processes or changes to documentation requirements.
Collaborates closely with Global Development functions, to ensure that CAPA fulfilment activities are defined, measured, handled and that takeaways are leveraged to improve efficiency and quality of clinical trial collection, analysis, reporting and submission across studies.
Defines and implements a minimally intrusive internal review approach to identify potential quality problems in ongoing studies and facilitate proactive remediation before minor issues become significant quality risks.
Coordinate with CDM Portfolio Head and CDM CDU Heads to assess the portfolio of ongoing and planned studies to understand the near term, medium-, and longer-term likelihood for future DM-related inspection targets.
This role may be for you if:
Represented Clinical Data Management in cross functional process discussion to ensure core needs of the department are met with regard to CAPAs and other process improvement initiates.
Have experience providing input to undertake the implementation and maintenance of global working practices and standards. Contributing to development of appropriate job aids to facilitate adherence to process and documentation requirements.
Demonstrate expert knowledge of all applicable regulations including 21 CFR Part 11, ICH-GCP Guidelines and CDISC standards for data collections.
Consistent track record of leading studies and study teams in a data processing environment
Represented Clinical Data Management in cross functional process discussion to ensure core needs of the department are met with regard to CAPAs and other process improvement initiates.
Have experience providing input to undertake the implementation and maintenance of global working practices and standards. Contributing to development of appropriate job aids to facilitate adherence to process and documentation requirements.
Demonstrate expert knowledge of all applicable regulations including 21 CFR Part 11, ICH-GCP Guidelines and CDISC standards for data collections.
Consistent track record of leading studies and study teams in a data processing environment
To be considered for this opportunity you must have:
A Bachelors degree in Mathematics, Science or a related field with a minimum of 12+ years of clinical Data Management experience in biotech, pharmaceutical or health related industry required.
#GDBDMJobs
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually) $176,900.00 - $294,800.00
A Bachelors degree in Mathematics, Science or a related field with a minimum of 12+ years of clinical Data Management experience in biotech, pharmaceutical or health related industry required.
#GDBDMJobs
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually) $176,900.00 - $294,800.00
