Inclusively is partnering with a pharmaceutical and biotechnology corporation to hire a Clinical Research Regulatory Manager.

ABOUT INCLUSIVELY:

Inclusively is a digital tech platform that connects candidates with disabilities, who may benefit from workplace accommodations, to inclusive employers. This includes all disabilities under the ADA, including mental health conditions (e.g. anxiety, depression, PTSD), chronic illnesses (e.g. diabetes, Long COVID), and neurodivergence (e.g. autism, ADHD). Applicants with one or more of these conditions are encouraged to apply; Inclusively does not require applicants to disclose their specific disability.

ROLE RESPONSIBILITIES

• Ensuring quality driven regulatory compliance of essential clinical documentation throughout the conduct of clinical research studies including IRB submissions, filing, distribution, and maintenance.
• Collaboration with various groups within the unit and across the organization to host audits and resolve audit findings.
• Responsible for the training and development of Clinical Research Regulatory personnel.
• Collaboration with colleagues to develop guidelines/policies for process standardization and cross-site load sharing.
• May act as a SME responsible for SOP updates and review within the function.
• Serve on various Phase I Unit team task forces to accomplish business needs and resolve issues.

ADDITIONAL RESPONSIBILITIES

• Lead projects, provide guidance and manage own time to meet objectives.
• Plan and schedule project timelines and milestones using appropriate tools.
• Manage and participate in pre-studies, projects and other activities for increasing operational efficiencies, change in business strategies or in support of operational imperatives.

BASIC QUALIFICATIONS

• Bachelor's Degree required
• 5 years of experience
• Phase I experience preferred
• Advanced Working knowledge of ICH and GCP guidelines required
• Pro-active and has a creative, entrepreneurial attitude with evidence of ability to execute key projects
• Excellent oral and written communication skills
• Must be willing and have the flexibility to work non-traditional hours in a 24/7 environment
• Proficiency with computer and software applications

PREFERRED QUALIFICATIONS

• Master's degree
• Specific experience managing pharmaceutical/technical/medical devices projects and/or clinical programs
• Knowledge and certification of operational excellence methodologies (Six Sigma and Lean etc.)

Work Location Assignment: Flexible

*Last date to apply is August 3, 2023*

Relocation assistance may be available based on business needs and/or eligibility.

Job Type: Full-time

Schedule:

• Monday to Friday

Work Location: In person