Senior Clinical Project Manager

Uniphar is a global partner to pharmaceutical and MedTech manufacturers, providing outsourced and specialized services through its Pharma division and other business units. The Senior Clinical Project Manager will oversee the execution of Phase I through Phase III clinical trials, managing CROs, vendors, study teams, timelines, budgets, regulatory compliance, documentation, and clinical data quality.

Responsibilities:

• Manages all study-related activities to meet defined study timelines, stated goals, budgets, while ensuring GCP/ICH guidelines and the relevant SOPs are met
• Responsible for vendor management as related to the study, in particular, oversight of CRO activities related to conduct of clinical studies
• Leads internal study team meeting with functional area representatives
• Responsible for leading and coordinating the development of study-related documents such as Clinical Project Plans, Informed Consent, Case Report Forms (CRFs), Monitoring Plan, Patient Diary, CRF Completion Guidelines, Safety Management Plans, Communication Plans, Clinical Study Quality Plans, and other relevant study plans and charters
• Maintains primary responsibility for the content of all study-related operational manuals, such as study operations manuals, pharmacy manual, and Service Provider manuals
• Oversees investigator recruitment/selection and the conduct of trials at investigative sites
• Participate as necessary in monitoring visits (co-monitoring), reviews monitoring visit reports and letters, and ensures CRO quality within trials
• Plans, executes, and leads Investigators' Meetings, if applicable; or may lead Site Initiation Visits, Clinical Research Associate (CRA)/Monitor training, and/or any other study related training
• Tracks study progress ensuring timely data collection, query resolution, monitoring, protocol adherence through the review of protocol deviations and, in collaboration with data management, through internal listings reviews
• Proactively escalates project-related issues to the Senior Management, or designee, to ensure timely resolution of issues
• Responsible for the quality control of clinical data of the assigned studies/ projects. Develops correction action plans, as necessary to ensure integrity of clinical data
• Provides Senior Management with regular study updates/status reports on study execution
• Contributes to knowledge management within Clinical Operations, proactively identifies potential study issues/risks and recommends/implements solutions, may lead lessons learned from previous studies to be considered in new study design and implementation
• Supports the preparation of standard operating procedures within Uniphar Development for management of clinical programs
• Assists in the planning of Data (Safety) Monitoring Boards, Safety Monitoring Committees, or other data review committees
• Participation in qualification/audit activities of CROs
• Reviews and provides input to vendor contracts and may contribute to contract and budget re-negotiation efforts
• Manages invoice reconciliation from all Service Providers
• Works closely with Uniphar Developments Project Management & Planning (PM&P) to forecastbudgets (actual vs. projected) on a periodic basis, including budgets provided by Service Providers; provides input to the integrated study timelines
• May be assigned sub-projects and may perform other duties as assigned by Uniphar Development Senior Management or designee

Requirements:

• BS/BA degree or equivalent (background in life sciences preferred)
• Eight or more years of clinical trial research management experience in a pharmaceutical, biotechnology or CRO setting with at least 2 years of project management experience; at least 4 years monitoring experience, with ability to independently perform all types of monitoring visits
• Demonstrated experience in managing multiple or complex projects across Phase I through Ill, including global clinical trials with multiple-CRO partners preferred, from start-up to database-lock
• Experience in management of CRO's, Service Providers, and contractors; with previous experience managing vendor contracts and budgets preferred
• Strong understanding and knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/lCH/GCP guidelines, is required
• Ability to work effectively (interpersonal, relationship management) with the study team, cross functional team members and external partners/Service Providers
• Strong operational, management skills with attention to detail, with excellent communication skills
• Requires proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Project
• Position requires substantial use of telephone and face-to-face interactions, which require accurate perception of speech. Position also requires extensive computer usage involving repetitive motions with fingers
• Willingness to travel up to 20%, depending on assigned responsibilities
• Advanced degree is preferred