Job description

Direct Hire!

Pay Rate: Up to $160k/year DOE

Bonus plan, 401k, Paid Vacation, and Benefits start on DAY ONE!

Summary:

• The Principal Study Operations Manager/Associate Director is at the heart of our Evidence Generation activities.
• The role provides operational leadership to the Clinical Study Team and is responsible for the planning, management, execution, and delivery of the trial.
• The role will require a robust use of project management tools and operational practices.

This role will provide YOU the opportunity to lead key activities to progress YOUR career and help us through our transformation. These responsibilities include some of the following:

• Study Team Leader and primary operational contact for 3-6 trials of average design and protocol complexity, including clinical trials, Rx-to-OTC Switch & associated behavioral studies, and decentralized/virtual trials. Trials are managed in North and Latin America.
• Has the ability and agility to manage the delivery of any types of studies (complex/ unusual study designs, new indications, challenging regional environment and local regulations) and strategically influence the operational delivery
• Responsible for the implementation, conduct and tracking of study trials in compliance with ICH/GCP and local regulations, company SOPs and written standards for the conduct of human subject research, study timelines, within budget and to project specifications. Provides operational and strategic leadership to assure successful delivery of trials.
• Acts as Business Owner and performs oversight of clinical sites, third parties/CROs and vendor activities according to the Functional Service Provider (FSP) or Full-Service Outsourcing (FSO) models
• Acts as a HBS Custodian
• Lead the coordination of cross-functional department activities to successfully achieve milestones and quality deliverables in study management, including but not limited to study start-up, recruitment, study conduct, and database lock and study close-out with risk and issue management and assurance of TMF inspection readiness.
• Contributes to the plans and study documents from an operational standpoint, such as protocols, informed consent forms, monitoring plans, vendor contracts, clinical study reports, etc.
• Leads or participates in clinical site assessments, vendor and due diligence/audit activities, and provides subject matter expertise on business improvement initiatives and change implementation.
• Mentoring of peers

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree in Science or Health-related field
• 5 + years experience in managing clinical research studies, clinical operations or equivalent.
• Project management/leadership experience in a matrix environment is required.
• Experience and understanding of clinical research and clinical trial management, associated regulatory processes, and quality requirements.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Advanced Degree in Life Sciences
• Track record of success in continuous improvement, innovative work practices and driving changes.
• Demonstrated business acumen, team leader experience either directly and/or as a matrix organization, as well as representing an organization with external stakeholders, including for example, Contract Research Organizations, Investigational Sites, Healthcare Organizations and External Experts
• Experience in RWE, Decentralized/Virtual trials, and Rx-to-OTC Switch and behavioral studies is appreciated.

Job Type: Full-time

Pay: $130,000.00 - $160,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Supplemental pay types:

• Bonus pay

Education:

• Bachelor's (Required)

Experience:

• Managing Clinical studies/trials: 5 years (Preferred)
• Managing clinical operations: 5 years (Preferred)
• Project Management: 1 year (Preferred)
• RWE: 1 year (Preferred)
• Rx-to-OTC Switch: 1 year (Preferred)

Work Location: Remote

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