- Contract Opportunity
- Client-Dedicated Position
- Remote Work - Work from Home
- Once travel restrictioncs are lifted, if located in the United States you will be required to travel to Boston 1-2 times a month.
- Once travel restrictioncs are lifted, if located in Belgium you will be required to travel to Ghent 1-2 times a month.
- May serve in a Project Lead role, Oversight Director role or People Manager role within the Project Delivery Organization. Serves as the Project Lead and primary sponsor contact. Oversees the overall delivery of the project (quality, time, cost) on behalf of the organization. Establishes and communicates customer expectations to the project team with minimal direction. Serves as a point of escalation and ensures pathways are adhered to internally and externally. Leads the cross-functional project team to meet or exceed deliverables. Manages project(s) of increasing complexity (such as but not limited to: multi-service, multi-region/country, therapeutic complexity, financial scope).The Oversight Director is accountable for strategic indication or client-specific portfolio management within a Therapeutic Unit. Provides therapeutic expertise in project delivery execution, demonstrating the ability to react quickly and appropriately to escalations. Provokes critical thinking in the Project Lead related to delivery operations, financial negotiations and risk mitigations/issue management for a project. Drives the overall strategy development for proposals and pre-proposal opportunities.The People Manager directs a team of Project Delivery direct reports of differing levels of experience and project roles within a Therapeutic Unit. Oversees the career development and performance management of their team, providing coaching in both soft skills and technical skills as related to the use of organization systems, tools and processes. Identifies training gaps and implements strategic solutions, while driving employee motivation and trust. Provides leadership to the department and fosters the ability to collaborate and balance business need with career development opportunities.
- Approves courses of action on salary administration, hiring, corrective action, and terminations.
- Serves as a Project Lead role, Oversight Director role:
- Project Lead responsibilities:
- Serves as the primary contact and subject matter expert between the sponsor and the organization at the project level.
- Serves as a point of escalation and ensures escalation pathways adhered to internally and externally (Rules of Engagement –communicationpathways).
- On projects where the scope requires, ensures clear delineation in responsibilities and communication pathways for secondary project leads (such as lead in a specific region, lead for a specific vendor(s) or subset of delivery).
- Drives and ownsthe strategic direction and overall delivery of the cross-functional project (time, cost, quality).
- Oversees the financial stewardship at a project level by demonstrating an intimate understanding of the contract, resource alignment to budget, management of Out of Scope activity, drive the Con Mod process/negotiations and team execution to timelines.
- Drives business by ensuring management of customer expectations to achieve optimal delivery during the project.
- Drives Risk Identification and Issue Resolution at project level (RBQM/RESOLVE).
- Ensures project team compliance with organization policies, SOPs, ICH-GCP, regulatory and project specific requirements.
Education and Experience:
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12 years).
- 5 years of management responsibilityStrong leadership skillsIn some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
- Advanced, broad understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC, publishing, etc.
- Advanced understanding of medical terminology, statistical concepts, and guidelines
- Sharp analytical, investigative and problem-solving skills
- Advanced financial acumen with an in-depth of knowledge and practical application of budgeting, forecasting and resource management
- Recognized executive presence and consultation and presentation skills
- Effective critical and strategic thinking skills that accounts for a broad impact
- Project Lead:
- Excellent customer service and relationship building skills and proven ability to provide strategic input into customer management in a complex environment
- Excellent negotiation and marketing skills with ability to influence internal and external stakeholders and drive results
- Superior judgment, decision making, escalation and risk management skills•Solution oriented with a demonstrated ability to drive innovation
- Project Oversight:
- Strong coaching and leadership skills•Excellent customer service, relationship building and stakeholder management skills
- Expert negotiation and marketing skills with ability to influence others and drive results•Superior judgment, decision making, escalation and risk management skills•Proven ability to drive corporate strategies to capture, engage and retain repeat customers