Clinical Project Manager
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is an integrated specialty pharmaceutical company powered by a robust U.S. generics business and a growing branded business. The company has a noble and important mission: We make healthy possible.
Amneal is one of the fastest growing pharmaceutical companies in the U.S. and makes healthy possible through its diverse product portfolio that includes more than 200 generic product families, 5 marketed specialty products, and a portfolio of biosimilars, one of which has been filed with the FDA, one near-term filing opportunity and one in late-stage development.
Additionally, Amneal has impressive R&D capabilities that have resulted in one of the industry’s largest generics pipelines with 258 products filed or in development, one investigational drug to augment the Specialty business, and three biosimilars in various stages of development. Amneal’s product range spans injectables and steriles, topicals and transdermals, solid and liquid dosage forms and inhalation delivery systems.
Following its May 2018 combination with Impax Laboratories, Amneal is uniting its 6,500 employees worldwide - who are based across the US, India, and European locations – around its Learn, Lead, Succeed culture. This dynamic entrepreneurial culture encourages all employees to contribute, to work together and to balance strategic thinking/risk taking with the need to achieve results.
As integration work continues, the company is centralizing much of its leadership and key functions in the Bridgewater, NJ area, including the majority of the R&D function. This has resulted in the need to hire several key roles to ensure the continued growth of the business and bring the function together, thereby enabling operational efficiency, close collaboration within the team, and the sharing of ideas and values.
From a Specialty Pharma perspective, Amneal has two large Ph III studies underway for the treatment of Parkinson’s Disease and one Ph IV study for pediatric usage of Zomig. However, Amneal is aggressively continuing to pursue growth through its business development initiatives, and it is anticipated the Clinical Product Pipeline will be greatly expanded in the near future.
Clinical Project Managers play an important part in the clinical trial process. The CPM position will perform a wide variety of activities to support the start-up and completion of clinical research studies.
• Support the management of all clinical programs underway in the company, which are essentially late-stage studies through to successful filing, subjects and an NDA submission.
• Act and serve as a team leader to coordinate and lead the project team that includes internal and external team members (e.g. Clinical Operations, Clinical Research Organization (CRO), CMC, and all other Outsourcing Partners).
• Ability to demonstrate innovation by contributing to group growth and being proactive in the areas of problem solving and efficient use of resources, as well as ability to change and grow with organizational and project needs.
• Ability to manage financials associated with clinical programs.
• Ensure adherence to organization policies.
• Maintain current knowledge of organization’s standard operating procedures (SOPs), local regulations, and participate in review of all SOPs including providing input.
• Participate in and contribute to training seminars/programs, train other employees (as appropriate).
• Achieve study objectives by working with team members to set project priorities and milestones and resolve project conflicts.
• Assess the operational feasibility of studies and recommend execution and risk mitigation plans.
• Co-monitor as needed.
• Develop and track study timelines, budget, and quality metrics.
• Ensure GCP and regulatory compliance is maintained.
• Lead the development of study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc.
• Maintain professional expertise through familiarity with therapeutic area and clinical research literature.
• Manage clinical projects from concept through clinical study report completion.
• Oversee clinical research study conduct.
• Lead regularly scheduled cross-functional study team meetings with internal and external resources.
• Participate in CRO and other vendor selection, negotiation and management, including monitoring of associated budgets and contracts.
• Participate in meetings with investigative sites, key opinion leaders and consultants as needed.
• Play a part in the analysis, summary, and reporting of clinical data through the course of the study.
• Aid in the training and development of all clinical staff members.
• Proactively identify and resolve issues, and participate in process improvement initiatives as required.
• Respond promptly and appropriately to study questions and issues raised by investigative sites, vendors, monitors, and consultants.
• Evaluate monitoring reports with significant findings to confirm appropriate conclusions and actions taken.
• Review serious adverse events and other pertinent data with the medical monitor and drug safety personnel to identify safety trends and potential risks.
Professional Experience / Qualifications
• Minimum eight years of Clinical Research experience, at least 3-5 years as a Program Lead or Clinical Project Manager at a pharmaceutical/biotech organization or a CRO.
• Thorough understanding of FDA, ICH, and GCP guidelines.
• Broad understanding of clinical operations related to clinical development functions.
• Ability to lead multi-disciplinary, cross functional teams - both internally and externally.
• Detail and team oriented with excellent cross functional team leadership and participation skills.
• Excellent interpersonal, verbal and written communication skills.
• Excellent organizational and problem-solving skills.
• Effective time management skills.
• Ability to manage competing priorities and self -motivated.
• Conscientious, influential person with an outstanding work ethic and strong personal discipline.
• Experience in writing clinical study protocols, informed consent forms, and other clinical documents.
• Solid understanding of FDA and other regulatory requirements that may impact global clinical studies.
• Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management.
• Willing and capable to manage multiple projects, negotiate budgets, timelines and responsibilities.
• Working knowledge of MS Project for development and update of clinical study timelines.
Bachelors/Masters in life sciences / Pharmacy / Nursing or equivalent.