Clinical Operations Manager

Company Name: Amneal Pharmaceuticals

Job Description

Description:

The Clinical Operations Manager will be responsible for supporting the Director, Clinical Operations successfully lead all clinical operational aspects of phase I – IV global clinical trials. This role will support the execution of clinical operations strategy, the planning, initiation, and execution of 1 or more clinical trials, including vendor selection, contracts and budgets, vendor oversight and management. Proactive risk identification is required to ensure on-time delivery of quality trials that meet the highest level of compliance, related to global and/or local clinical trials from the study start-up to the clinical study research report.

Essential Functions:

• Primary contact for CRO Clinical Trial Manager, Project Manager. Primary contact for CRO legal and Internal legal for Clinical Trial Agreement negotiation/ escalation and for Letter of Indemnification negotiation/escalation. Primary contact for CRO study start-up team for clinical site budget escalation. Receives and distributes project documents for internal Amneal review, such as ICFs, operation manuals, and study plans. Escalates questions from CRO to internal Amneal Team.
• Under the direction of the Director, Clinical Operations, determine timelines, goals and objectives and ensure the successful execution of multiple clinical trial projects in different therapeutic areas in a timely manner.
• Involved in the CRO selection process, including but not limited to the review of Request For Proposal documents, participation in Bid Defense Meetings and determining deliverables.
• Lead the Study Team and contribute to the Study Concept development with regard to operational aspects; develop the comprehensive overview and operational plans for the study, including the creation of essential project documents, such as protocols, CRFs, ICFs, safety updates, and clinical study reports.
• Review CRO invoices against statement of work and ensure accuracy. Review CRO trip reports and seek clarifications on monitoring issues.
• Reviews and approves site and vendor invoices, including investigator grants and pass through costs against statement of work and ensure accuracy.

Additional Responsibilities:

• Provide internal support with the monitoring of clinical trial data and issues associated with the data.
• Works closely with internal Regulatory and Compliance teams to provide clinical content input for IND Submission documents Sunshine Act Reporting and ClinicalTrial.gov summary updates.
• Involved in the review process of Clinical Operations study documents provided by the CRO.

Qualifications

Education:

• Bachelors Degree (BA/BS) Health Sciences - Required
• Master Degree (MS/MA) - Preferred

Experience:

• 8 years or more in Relevant healthcare experience or 5 years clinical operations experience in the pharmaceutical industry
• 4 years or more in Monitoring and/or Clinical Trial/Study Management experience

Skills:

• Strong interpersonal skills with an ability to communicate with people at all levels of an organization - Advanced
• Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures. Must be focused and able to meet tight timetables - Advanced
• Adaptable and able to work in an environment where priorities are constantly changing - Advanced
• Ability to effectively present ideas and document concepts in writing and orally - Advanced
• Ability to comprehend complex scientific concepts - Advanced
• Proficiency at finding and implementing creative solutions, and exceptional time management and with proven project management skills required. - Advanced
• Excellent interpersonal and decision-making skills. Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives. - Advanced
• Ability to manage multiple projects. Possesses excellent planning, time management and coordination skills. - Advanced
• Demonstrated ability to use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs. - Advanced

Specialized Knowledge:

• Knowledge of GCPs, ICH guidelines and FDA regulations. Familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements is a plus.
• Comprehensive understanding of ICH/GCP requirements, principles, concepts, as well as industry standards and practices.
• Maintains computer literacy in appropriate software
• Knowledge of all phases of drug development: Phase I – IV global clinical trials across multiple therapeutic areas.

The annual salary for this position ranges from $140,000-155,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award with this position within the first 12 months. Amneal ranges reflect the Company’s good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.

At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.