Project Manager, Optimized Trials

Description

SUMMARY:

The Project Manager (PM) is focused on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction. The PM works collaboratively with key internal and external stakeholders to develop study specific processes, manage communication across all involved parties, create and maintain study timelines. The PM oversees all aspects of assigned projects by setting expectations and deadlines, aligning tasks with appropriate resources, and monitoring and progress of project to completion. The PM directs project delivery by driving team and financial efficiency, work product quality, and is responsible for client satisfaction through effective relationship management.

Requirements

ESSENTIAL DUTIES:

• Responsible for the oversight of day-to-day study operations for assigned projects, working closely with the sponsor/CRO and other selected vendors for the assigned project(s)
• Ensures that deliverables for assigned project(s) are completed according to the contract budget, schedule, and quality standards. Effectively manages projects in all areas of performance.
• Reviews study requirements and response assessment criteria, collaborating with key stakeholders to execute study start-up, conduct and close-out activities according to the customer’s and company’s contractual agreements.
• Creates, maintains, and implements definitive project plans (i.e. timelines, milestones, enrollment and requirements for project staff).
• Tracks project deliverables against contract using Elligo’s tools. Proactively prepares/presents study metrics to maintain transparency for internal/external stakeholders.
• Monitors trends and drives changes to the plan as needed; identifies risks to delivery and collaborates with the project team to develop mitigation plans to be presented to the client.
• Responsible for project management deliverables including, client update presentations, recruitment trackers, consent forms and site training materials, including project reporting schedules
• Sets objectives of the core project team and/or sub-team(s) according to the agreed upon contract, strategy and approach, effectively communicate and assess performance.
• Interacts with clients and vendors to ensure that all contractual obligations are being met.
• Determines resources required for project completion and communicating needs to appropriate departmental managers.
• Ensures projects are executed in accordance with Good Clinical Practice (GCP), relevant Standard Operating Procedures (SOPs), and regulatory requirements.
• Coordinates activities and deliverables of all study team members, including training.
• Develops contingency planning and risk mitigation strategies to ensure successful project delivery.
• Provides oversight for study documentation and ensuring project records remain inspection ready.
• Performs financial tasks including monthly billing, forecasting, project scope reviews and amendments, along with pass-through cost management.
• Analyzes project performance for consistency/quality within established project guidelines.
• Hosts regular project meetings with customer(s) to share key updates and current performance.
• Builds positive customer relationships with the goal of acquiring net new awarded projects.
• Effectively communicates project specific reports to external stakeholders in accordance with strategic objectives of the organization
• Oversees the full life cycle of regulatory activities from study start-up to study closure and record retention of projects assigned to, including collaborating with external vendors to ensure critical timepoints are met for regulatory submissions as appropriate
• Assists in Quality Management, Inspection Readiness and supporting audits
• Performs other duties as required and/or assigned.
  
  

Qualifications

• Strong understanding of study contracts, budgets, regulatory, and fiscal management.
• Outstanding interpersonal and client relationship skills with the ability to build and foster positive relationships.
• Skillful at managing conflicts, ensures win/ win negotiations and gains respect from clients and internally and viewed as the driver and owner of the overall project.
• Excellent verbal and written communication skills, including the ability to effectively convey ideas and information with clarity.
• High attention to detail and produce accurate work.
• Strong organization/prioritization skills for the management of multiple concurrent projects with competing deadlines.
• Capacity to lead and provide direction to others.
• Ability to work with functional groups and different levels of employees throughout an organization to achieve business results effectively and professionally.
• Proactive and timely follow-up skills: the ability to organize applicable department timelines and follow up with internal and external stakeholder needs as needed.
• Self-motivated, including the ability to work independently to complete tasks, respond to department requests and collaborate with others to utilize their resources and knowledge to identify quality solutions.
• Skilled in interacting and working with others, including peers, patients, management, and internal and external stakeholders.
• Working knowledge of Good Clinical Practice guidelines and Federal research regulations.
• Familiarity in clinical trial terminology and practices required.
• Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS Office products such as Excel and Word.
• High comprehension and in depth knowledge of HIPAA privacy and security laws and PHI
• Adaptable in a fast-paced environment with changing priorities, tasks, and client conditions.
• Strong customer service skills with an ability to work under pressure and conflicting client deadlines and requests.
  
  

Education And Experience

• BS/BA in Life Science or related discipline or relative experience.
• Minimum three (3) years of clinical trial or relevant experience, including experience utilizing clinical trial master filing systems
• Four (4) or more years project management or equivalent experience, including executing project plans, timelines, and budgets
• Minimum one (1) year of experience managing teams, managing projects, and directly or indirectly facilitating workgroups
• Minimum five (5) years of experience customer service experience, with at least one (1) year of client relationship management experience
• Over one (1) year of financial management experience, including overseeing and managing project level budgets
• At least three (3) years of experience working with or working for local or central IRBs/IBCs
• Experience in working in hybrid/decentralized trial models is preferred.