Late Stage Project Manager
Continuum Clinical, a part of Blue Chip Worldwide, is a healthcare research and communications company that helps clients achieve clinical and commercial excellence through innovative thinking and a full continuum of distinctive services. Specializing in Late Stage Research, Continuum Clinical provides proven solutions in marketing, consumer and physician communications, post-approval research, and health economics.
We exist to give incredible people opportunity to make a difference.
- Kind & Compassionate
- Pride of Ownership & Accountability
The exempt management role reports to the Executive Vice President, Observational Research and Registries. The role of this Project Manager is to estimate, plan, execute, and complete assigned projects – primarily registries and other types of observational studies in accordance with established timelines and budgets agreed upon by Continuum and the sponsor, while at the same time employing a flexible and creative approach to ensure that the operational approach employed is customized to meet the specific needs of each study. The responsibilities of the Project Manager include acquiring, assigning, and managing resources, and coordinating the efforts of employee staff and other resources such as consultants and third-party subcontractors, in order to ensure the most efficient and effective approach to addressing the study’s overall strategic objective(s). The Project Manager is also responsible for the accuracy and timeliness of all financial data and reports, and ensuring that the study is completed in an efficient and effective manner
Essential Duties and Responsibilities:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Other duties may be assigned.
- Demonstrate the mission, vision, values, and culture principles of Blue Chip Worldwide/Continuum Clinical.
- Oversee all operational aspects of assigned project
- Provide effective leadership to all members of the Project Team
- Delegate tasks and responsibilities to appropriate personnel, identify and resolve issues and conflicts within the project team
- Coach, mentor, motivate and supervise project and support employees and subcontractors;
- influence these partners to take positive action and be accountable for their assigned areas of responsibility
- Develop detailed execution plans, and all other necessary project communications and reporting documents
- Oversee study training for all members of the Project Team
- Identify, build, and leverage effective relationships with external advisors, clinical investigators, vendors, and applicable research staff
- Develop and update the project schedule, timelines and milestones, and contently ensure that all critical path activities are performed in accordance with the established schedule
- Develop and deliver schedule progress reports and financial performance reports, and assume responsibility for all aspects of project finances, including but not limited to accurate study budget forecasting, allocation, and actual spending
- Proactively manage changes in project scope, identify potential issues, and devise contingency and recovery plans
- Monitor conduct of study procedures to ensure protocol compliance and obtain subject matter support as needed
- Ensure that all company, client, and regulatory policies and procedures are followed in all aspects, and that any incidents are reported as soon as possible to client and company management
- Be accountable for selection of appropriate study sites and/or overall vendor and consultant management as needed, and assume responsibility for corrective action plans at individual sites and across the project
- Assume responsibility for the identification of project risks and the development and implementation of the mitigations to address those risks
- Liaise with the client project management team, company management, and any other parties associated with the project on regular and ongoing basis
- Set and continually/actively manage project expectations with project and support employees and other stakeholders
- Provide timely insights to Continuum’s Senior Leadership Team regarding the operational and financial conduct of the Project, and recommendations regarding areas where improvement is required
- Define project success criteria and disseminate them to all involved parties throughout the project duration
- Help build, develop, and grow the company’s business relationships with the sponsor
- Conduct project “lessons learned” reviews, create a “Recommendation Report” to identify successful and unsuccessful project elements, and develop best practices and tools for project execution and management.
- Oversee the preparation of final reports, publications and other key deliverables
- Must be able to travel occasionally overnight and on weekends.
- Complies with all corporate and departmental standard operating procedures as well as FDA and other governmental regulations (e.g., IRB, EC).
- Ensure that each project is conducted in accordance with company standard operating procedures (SOPs), relevant practice guidelines such as Good Pharmacoepidemiology Practices (GPP), and specific country regulations, as applicable
- Ensures all activities and operations are performed in compliance with regulatory and federal regulations.
- Responsible for maintaining up to date weekly time tracking, per the Agency’s time tracking policy.
- As a manager, you are also responsible for ensuring that your direct reports maintain up to date weekly time tracking, per the Agency’s time tracking policy.
- Based on client and internal project demands, additional duties may be assigned.
Education, Experience and Certifications
- Bachelor’s Degree from an accredited four-year college or university preferred.
- Seven (7) or more years’ experience in a clinical research environment, working as a Clinical Research Coordinator, a Clinical Trial Assistant, Clinical Research Associate, Lead Clinical Research Associate or Project Manager
- Three (3) or more years of experience working as a Clinical Research Associate or a Lead Clinical Research Associate, or in an equivalent position
- One (1) or more years or experience working on Phase IV, Post-Approval, Late Stage, Health Economics and Outcomes Research or Observational Studies
- Excellent written, verbal and presentation skills
- Superior organizational skills with attention to details
- Ability to work with little or no supervision.
- Ability to use diplomacy and tact when dealing with problems
- Ability to identify problems and determine the best course of action for their resolution
- Ability to critically evaluate information for accuracy and usefulness in solving problems.
- Excellent written, verbal and presentation skills.
- Ability to use standard office equipment such as computer, keyboard, etc., and proficiency with standard software, such as Word, Excel, etc.
Continuum Clinical Qualities
To be successful, every Continuum Clinical employee should possess the following qualities:
- Attitude & Commitment – you are a passionate, resourceful and productive achiever that is a pleasure to be around
- Priority Setting – you define clear action steps and manage expectations of others
- Creative Thinking & Problem Solving – you recognize the relevancy of your ideas to the big picture, demonstrate original thinking and make an impact on your team
- Dependability – you are self-motivated to deliver the highest quality work, on time and budget
- Leadership Ability – you take initiative, motivate others and assume accountability for your actions
- Communication – you use organized, constructive communication to facilitate great work
- Continuum Clinical