Senior Clinical Project Manager

Senior Clinical Project Manager

Remote in the Northeastern US

Pay: $150,000 - $175,000 + Bonus

The Senior Clinical Project Manager (Sr CPM) will be responsible for the overall execution of clinical operations activities on behalf of Uniphar Development Partners for trials spanning Phase I through Phase III.

The Sr CPM serves as the primary contact to Contract Research Organizations (CROs), Service Providers, site investigators, study personnel, as well as internal Uniphar Development functional areas, the Product Development Team (PDT) members, and the Partner to relay trial progress, status and/or issues associated with the daily operations of one or more clinical trials. The Sr CPM will be responsible for all aspects of the clinical trial from pre-study planning, protocol review, management of CRO(s) and other 'Service Providers, through clinical study report finalization for regulatory submission. The Sr CPM will ensure trial conductivity follows ICH-GCP, FDA/EMA, or other regulatory health authorities, and Standard Operating Procedures (SOPs), as applicable. The Sr CPM will also ensure all operational trial deliverables are met according to project agreement(s), timelines, budget, operational procedures, and quality standards.

Key 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 forecast budgets (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
• This role requires 20% travel.

Qualifications:

• BS/BA degree or equivalent (background in life sciences preferred). Advanced degree is 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 III, 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/ICH/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

Organizational Relationships:

• DIRECT REPORTS: 0-2 individuals
• Frequent interaction with internal and external staff, and Uniphar Development Senior Management.
• Frequent interactions with internal and external groups as a project management representative.
• Interactions concerning contract and budget re-negotiations.

Physical Requirements:

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.

Equal Opportunity Employer

Uniphar recognizes the right of an individual to work and to advance on the basis of merit, ability, and potential. It is the policy of Uniphar to ensure that job applicants are considered, and that employees are treated during employment, without regard to their race, color, religion, creed, sex, national origin, age, physical or mental disability, veteran status or Vietnam-Era veteran status, citizenship, marital status, domestic partnership status, familial status, gender identity, sexual orientation, legally protected medical condition (including pregnancy, childbirth, or related medical condition), genetic characteristics or other characteristic, condition or classification protected by federal, state, or local law. Uniphar is committed to the principles of equal opportunity and resolves to ensure equal opportunity in all employment practices.