Summary of Key Responsibilities: The Senior Clinical Project Manager (Sr. CPM) is responsible for overall management, coordination, and supervision of multiple clinical research trial projects (including global projects) to ensure timely delivery of required objectives and timelines within the scope of clinical trial agreement and project budget. Serves as the principal liaison with clients to ensure effective and timely communication of project progress, issues, and plans for resolution of those issues. Provides leadership in the development of clinical trials and related documents. Ensures cross-functional team, compliance with SCRI Standard Operating Procedures, Good Clinical Practice and International Conference on Harmonization (ICH) guidelines and other applicable regulations. Works closely and effectively with physicians, principal investigators, research directors, clinical trial sponsor, study teams, and outside consultants. Mentors and assists in the development of project team members. Provides strategy and input in business development proposals and attends bid defenses.
Duties and Responsibilities:
Duties include but are not limited to:
Project Guidelines and Communication:
Develops clear and measurable project management plans in conjunction with the Senior Director, Clinical Development and Sponsor representative(s).
Global management of clinical projects/programs, including deliverables from all functional areas and vendors in accordance with contractual timelines, sponsor specifications, quality, and GCP.
Defines timelines, milestones, and limitations to project staff.
Establishes project metrics and project report schedules with client representatives. Provides project updates as required per contractual agreement
Develops and executes complex study plans in one or more clinical studies with minimal supervision. High complexity projects or programs may be allocated based on experience level and competencies.
Provides oversight and integration activities of all operations staff supporting assigned projects, draft plans for multiple related studies, with oversight.
Acts as the primary liaison between the project team and the sponsor/customers and service providers.
Is an expert on assigned protocols. Demonstrates ability to integrate and summarize
medical/scientific concepts in protocols and other documents. Proactively seeks out and recommends process improvements.
May include responsibility for oversight of a program of related studies grouped by indication, molecule or Sponsor.
Ensures external and internal documentation is completed in accordance with SCRI SOPs and GCP regulatory requirements and consistent with the protocol, for all assigned programs/trials.
Project Analysis and Management
Identifies critical project success factors for tracking, analysis and reporting including probability and impact of potential project risks.
Manages adherence to project budget & contracts and assists in the identification and development of scope change documents.
Monitors project status, budget expenditures, and identifies problems and recommends solutions.
Coordinates assignment of needed resources for project conduct and completion with functional area leaders; ensures appropriate staffing to accomplish project goals within budget.
Develops budget and expense review strategy; creates scope definition documents and creates proactive cost containment strategies and communicates with project team and Finance; regularly reviews budget/expenses with project team.
Identifies out of scope work and initiates the scope change process with sponsor representatives.
Ensures the site contract and budget negotiation process is completed in accordance with project timelines and coast parameters.
Responsible for review and approval of project grants and financial records (invoicing/units/expenses) in conjunction with appropriate project team members and Finance.
Accountable for development, oversight, and delivery of project team training.
Provides active mentorship and training of project team staff to build talent across the department.
Determines what project processes are needed, trains and maintains project team knowledge/application of project processes.
Establishes and communicates team performance expectations and guidelines.
Manages performance of all service providers, delegating appropriate and challenging assignments to encourage growth, development and responsibility.
Manages team and individual performance appropriately.
Promotes effective teamwork among functional teams and provide day to day direction for core
Initiates improvements to enhance the efficiency and the quality of the work performed on
Communicates and escalates unresolved issues at the appropriate time and to the appropriate
level of management.
Participates in development and review of departmental Standard Operating Procedures (SOPs), guidelines, and intradepartmental procedures and other continuous process improvements programs, as assigned.
Collaborates with Sr. Director, Clinical Development, Project Management team, Directors, Business Development in the development/presentation of SCRI Development Innovations capabilities/proposal defenses.
Builds and maintains strong pharmaceutical industry sponsor and organizational team relationships for the success of clinical trial management.
Identifies organic growth opportunities within the client's business and exercises meaningful influence within the client's organization to drive repeat business opportunities.
Contributes to new business development by offering expertise during strategy sessions, proposal development and client presentations,
Represents SCRI Development Innovations at professional, marketing, bid defense, and business/scientific meetings.
Participates in and contributes to publication strategy and content.
Practices and adheres to the 'Code of Conduct' philosophy and 'Mission and Value Statement'
During your employment with SCRI you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.
Knowledge: A body of information needed to perform a tasks; May be obtained through education, training or experience
Extensive knowledge of clinical research: Understands the drug development process. Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities. Ability to review protocols, programs, and assess the success of a project. Strong understanding and knowledge of budgeting, forecasting, and resource utilization.
Skills: The proficiency to perform a certain task
Extensive management skills demonstrated by calm and thorough review of situations. Proactively identifies and or addresses problems. Seeks to understand all contributing factors. Proposes, implements, and evaluates appropriate solutions.
Demonstrated leadership skills - successfully managed large project teams.
Strong communication and presentation skills - Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive Sponsor, project team member and internal relationships. Ability to conduct effective presentations.
Computer skills with ability using clinical trial management systems, clinical trial databases, and electronic data capture.
Abilities: An underlying, enduring trait useful for performing duties
Interpersonal skills, detailed-oriented and meticulous.
Resourceful with heightened analytical abilities and problem solving skills in a fast paced
Organizational and prioritizing capabilities.
Ability to manage projects in culturally diverse settings - knowledge of different cultural sensitivities within regions and/or countries that could impact the progress of a clinical trial(s), and an ability to use that knowledge to manage relationships and to share that knowledge with the larger project team.
Education- Bachelor's Degree
Type of Experience-
A minimum of 5 years of clinical trial experience within pharmaceutical, biotechnology, CRO company and/or healthcare setting, i.e. managing the logistics of clinical trial conduct, budgeting/forecasting, and developing/executing project plans Experience in healthcare research or other science related field
Previous experience as a Clinical Project Manager