SUMMARY: The Project Manager, Evidence, is responsible for the overall coordination and management of observational research projects, comprising large, national, international, or global studies and/or complex studies to meet the needs of a variety of stakeholders across the entire healthcare value chain. From start-up through successful completion, the Project Manager is responsible for all operational study components: serving as the sponsor's primary point of contact, managing the internal project team, ensuring milestones are achieved per the timelines, adhering to the budget, managing the study's scope, employing a flexible approach customized to meet each study's needs, ensuring the appropriate procedures and processes are followed, managing vendors, providing excellent and high-quality services, and updating internal tools in support of the project(s).

Real World Evidence (RWE) / non-interventional study experience at a CRO, biotech or pharma is required.

• Oversees and directs all operational, financial, and technical aspects of assigned project(s); escalating key issues to Senior Management, as appropriate
• Leads the internal project team, working with functional area leads across internal units, to identify, evaluate, and efficiently address fundamental project requirements and training needs
• Communicates regularly with sponsor(s) and Senior Management regarding budget, time, and quality requirements associated with milestones and key deliverables
• Ensures successful design, implementation, tracking and revision of project plans, monitoring the scope of services and being accountable for risk management, problem-solving, and contingency planning
• Provides a high level of customer service and builds solid relationship with sponsor(s)
• Utilizes internal tools (Sciforma, PPR, etc.) to monitor project scope and performance; maintains dialogue with Senior Management and internal team(s), as appropriate

RESPONSIBILITIES:

• Lead cross-unit coordination, both internal and external, inclusive of vendors and sub-contractors
• Strive to independently anticipate and solve complex sponsor issues in a timely and appropriate manner
• Initiate improvements to enhance the efficiency and the quality of the work performed on assigned project(s)
• Promote effective teamwork, motivating team members and encouraging them to take positive actions and be accountable; resolve conflict, when needed
• Ensure appropriate communication on project-related matters with Senior Management
• Understand study budgets and take appropriate steps to meet financial performance targets for assigned projects
• Ensure that staff allocated to assigned projects are trained on the study protocol and adhere to professional standards, SOPs, and study-specific processes
• Ensure that company, sponsor, and applicable regulatory policies and procedures are followed
• Contribute to and/or oversee the development of study deliverables (reports, publications and presentations); ensure deliverables are produced according to WCT and sponsor expectations
• Remain current with industry guidelines, regulatory requirements, technologies, etc. as it pertains to real world evidence and observational research
• Support staff and liaise with functional line management to identify training or development needs; provide input into the performance appraisal process for team members
• May work on multiple projects simultaneously
• Participate in regularly occurring meetings with Senior Management to keep them apprised of the project's status, successes, risks, and financial performance

OTHER SKILLS AND ABILITIES:

• Strong written, verbal, and presentation skills (English and local language)
• Superior planning, organizational skills with attention to details
• Strong leadership and interpersonal skills
• Confident decision maker
• Able to work with minimal supervision, in a team environment with an emphasis on collaboration and maintaining positive relationships with colleagues and sponsors
• Knowledge of project management principles, application, and cross-functional management (time, quality, cost)
• Able to delegate effectively and prioritize own and project team members' workloads
• Able to use diplomacy and tact with dealing with problems; able to negotiate and determine the appropriate course of action for resolution
• Strong financial acumen: knowledge of budgeting, forecasting, and resource management
• Solid understanding of clinical research principles and processes
• Able to review, assimilate, and summarize complex medical information
• Cross-cultural awareness and ability to adapt appropriately
• Technologically proficient and responsible in remote work environment: able to use standard office equipment, software, and other business applications

REQUIREMENTS:

• University/college degree (life science preferred) from an accredited college or university
• Minimum of five (5) years relevant experience in clinical research environment; including demonstrated skills and competency in project management tasks
• In lieu of the above requirements, candidates with > three (3) years supervisory experience in a health care setting and four (4) years clinical research experience in the pharmaceutical or CRO industries will be considered and/or proven ability and demonstration of relevant experience and skills
• Experience managing late phase, post-approval, observational research studies, and/or other complex clinical studies
• Demonstrated skills and competency in clinical Project Management
• Track record of success leading and developing project teams
• Awareness of local and/or international regulatory requirements
• Proven experience developing and managing budgets and resources; competent using project management software
• Available for domestic and international travel, including overnight stays (valid passport)

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