Clinical Operations Manager

Antag Therapeutics; United States; On-site; USD 100,000 - 160,000; Full time

Job summary

A leading biotechnology company is seeking a Clinical Operations Manager responsible for overseeing clinical trials, ensuring project objectives are met while maintaining quality standards. The ideal candidate will have extensive clinical trial management experience and a bachelor's degree, with the ability to lead cross-functional teams effectively.

Qualifications

• 8+ years of clinical trial management experience.
• Thorough understanding of clinical trial processes and ICH/GCP guidelines.
• Ability to travel domestically and internationally.

Responsibilities

• Oversee study scope, quality, timelines, and budgets.
• Manage development of clinical trial documents and ensure compliance.
• Identify and manage study-related risks proactively.

Skills

Clinical Trial Management

Project Management

Budget Management

Interpersonal Skills

Problem Solving

Education

Bachelor’s degree or equivalent

Job description

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Antag Therapeutics is a biotechnology company dedicated to developing innovative peptide-based therapies to address obesity and related cardiometabolic disorders.

Our approach is rooted in decades of pioneering research from the University of Copenhagen, with a focus on the complexities of incretin physiology.

Overview Of Role: Clinical Operations Manager

The Clinical Operations Manager is responsible for all aspects of clinical trials (study start- up, maintenance and close-out) for assigned studies. The Clinical Operations Manager coordinates with internal Antag cross functional team members as well as leads and provides oversight to CROs and vendors for the timely, high-quality delivery of clinical study deliverables. The Clinical Operations Manager is a member of the broader Clinical Development Team and may be tasked with other duties related to departmental and/or company initiatives as assigned.

Role And Responsibilities

• Oversees study scope, quality, timelines, and budget with internal functional team members, CROs and vendors to ensure that overall project objectives are met.
• Partners with CROs and vendors to ensure strategies and plans are developed and carried out effectively to ensure study and corporate goals and objectives are met related to clinical studies.
• Proactively identifies and manages study related risks.
• Responsible for the development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreements as required.
• Responsible for reviewing and managing study related plans, processes including Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plans, data management plans, safety monitoring plans
• Responsible for the review of CRO and vendor contracts/work orders and specifications to enable study objectives to be met.
• Directs investigator/site/CRO/Vendor performance and adherence to protocols, processes and SOPs. Proactively addresses issues that pose a risk to timelines, quality standards, ICH/GCP guidelines.
• Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following appropriate SOPs.
• Other duties as assigned.

Experience, Education And Specialized Knowledge And Skills

• Bachelor’s degree or equivalent.
• A minimum of 8+ years of clinical trial management experience.
• A thorough understanding of full-spectrum (multifunction) clinical trial processes and ICH guidelines/GCP.
• Experience with budgets, forecasting and project management methodologies.
• Ability to travel domestically and internationally as needed.
• Demonstrated ability to lead and work in a fast-paced team environment.
• Experienced building relationships with internal team members, CROs/vendors, KOLs, Principal Investigators and site personnel.
• Excellent interpersonal and decision-making skills.
• Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives.
• Demonstrated ability to comprehend complex scientific concepts and synthesize, interpret and present data.
• Possesses excellent planning, time management & coordination skills.
• Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs.
• Experience working in a small organization/start-up environment preferred.
• Excellent written, oral communication and presentation skills.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

• Industries

  Biotechnology

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