Sr. Clinical Compliance Specialist - FSP
About The Position
Join Us as a Sr. Clinical Compliance Specialist - Make an Impact at the Forefront of Innovation The Sr. Clinical Compliance Specialist executes quality and compliance processes across the organization and facilitates the tracking and reporting of quality and compliance activities. Responsible for planning, monitoring, and reporting on quality and compliance for selected clinical trial delivery processes to determine adherence and understanding of ICH GCP requirements and processes. Contributing member of an independent team focused on clinical trial delivery quality assessment for ongoing operations and processes within supported functional areas. Performs proactive as well as routine evaluation of clinical trial processes to determine adherence to process and procedural documentation through documentation review and active engagement with study team functional representatives. MUST HAVE VEEVA eTMF EXPERIENCE Helps develop and maintain KPIs, metrics and dashboards to track process quality and compliance Provides near real-time feedback on study process and documentation quality as well as team performance and understanding on evaluated processes. Ensure compliance with own Learning Curricula, corporate and/or GXP requirements. Represent GCP Compliance in meetings as needed. Performs other duties as assigned. Education and Experience: Bachelor’s degree and minimum of 4+ years clinical research experience in pharmaceutical or biotechnology field Solid knowledge of drug development, clinical trial management and/or GCP compliance processes Proven track record of strong project management skills and experience managing clinical trial delivery activities for drug development programs. Experience in problem solving, negotiations and collaborative team building with non- direct reports and other stakeholders is required Solid knowledge of regulatory requirements governing clinical trial, industry best practices and related standard and documentation requirements Must be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management and presentations Effectively resolve conflict in a constructive manner In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Requirements
- Bachelor’s degree and minimum of 4+ years clinical research experience in pharmaceutical or biotechnology field
- Solid knowledge of drug development, clinical trial management and/or GCP compliance processes
- Proven track record of strong project management skills and experience managing clinical trial delivery activities for drug development programs.
- Experience in problem solving, negotiations and collaborative team building with non- direct reports and other stakeholders is required
- Solid knowledge of regulatory requirements governing clinical trial, industry best practices and related standard and documentation requirements
- Must be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management and presentations
- Effectively resolve conflict in a constructive manner
- Excellent oral and written communication skills
- Solid organizational and time-management skills
- Firm knowledge of the clinical trial process
- Thorough knowledge and understanding of ICH GCP and other relevant regulations and guidelines
- Effective problem solving skills
- Strong attention to detail
- Ability to work independently as required
- Strong computer skills; ability to learn and become proficient with appropriate software
- Ability to multitask and prioritize competing demands/work load
- Demonstrated flexibility and adaptability
- MUST HAVE VEEVA eTMF EXPERIENCE
Responsibilities
- Executes quality and compliance processes across the organization
- Facilitates the tracking and reporting of quality and compliance activities
- Plans, monitors, and reports on quality and compliance for selected clinical trial delivery processes
- Performs proactive as well as routine evaluation of clinical trial processes
- Helps develop and maintain KPIs, metrics and dashboards to track process quality and compliance
- Provides near real-time feedback on study process and documentation quality
- Ensures compliance with own Learning Curricula, corporate and/or GXP requirements
- Represents GCP Compliance in meetings as needed
- Performs other duties as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
