Clinical Project Manager(FSP)

Requirements

• Leadership skills that include:
• Ability to lead a virtual team across locations and cultures
• Carefully weigh the priority of project tasks and direct team accordingly
• Enlist the support of team members in meeting goals
• Ability to negotiate and influence with diplomacy in order to achieve

Benefits

Additional Information

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Key Accountabilities: Sponsor Liaison: Effectively communicate with internal and external customers as well as third party vendors; Prioritize effectively and respond to urgent requests within team or from sponsor. Project Initiation: Oversee and / or manage study start-up activities as applicable Provide inputs to project tools and study plans Provide inputs to the format and content for sponsor reports/templates, if applicable Provide input to and oversight of site selection strategy plan Develop site selection and monitoring plans Review and provide input into patient recruitment plan and retention plan Ensure all team members have access to study systems, tools and documents Establish efficient / effective working relationships with other Functional Leaders across geographies and within a given program Develop study plans, tools, forms and templates pertaining to Clinical Operations Provide input on relevant vendor plans, clinical supply strategy and management. Support vendor access and assist with troubleshooting vendor issues. Project Execution: Provide leadership and direction to project team members Identify, organize and deliver (where appropriate) study specific training in collaboration with Project Leader and Project Specialists Evaluate and identify resourcing needs and continuously monitor the use of resources over project life cycle. Provide study productivity targets to project team members Provide performance feedback on team members and work with line management, as appropriate To effectively recognize potential problem areas early and develop robust contingency and risk management plans, Monitor study timelines, patient recruitment, retention and data cleaning to ensure successful outcome of the project Liaise with vendors to support clinical activities Oversee maintenance and quality check of TMF Maintain and assure quality of work generated and escalate and follow up as appropriate Ensure appropriate handover between project team members with support from Clinical Operations Managers Implement and proactively initiate process improvements within the project, as and when needed Manage the clinical portion (e.g., COL, SSUL, CRA, iCRA) of the project according to the contracted scope and proactively monitors for changes in scope. Monitor cost drivers and actively seeks ways to optimize resources, ensuring efficiency and cost-effectiveness in clinical operations team In exceptional circumstances, may be required to conduct site visits as per sponsor or project demands Participate in sponsor, investigator and team meetings Prepare, participate in and follow up on audits / inspections Participate and deliver all required applicable trainings, as appropriate Project Close-out: Collaborate with project team (e.g. Project Leader and Data Management Lead) and relevant vendors on database lock activities Liaise with vendors to ensure process for return of clinical supplies from sites Together with Project Leader ensure all administrative closeout procedures are completed according to the close-out process Together with Project Leader ensure project is archived and all documentation returned to the sponsor as specified by the contract Participate in end of study meeting and give input to lessons learned information and feedback relevant information into the relevant functions Operational: Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and Parexel WSOPs, SOPs, Operational Guidelines, Work Instructions and study specific procedure Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, office and travel expense claims) Responsible for reviewing site qualification, initiation, monitoring, and close-out visit reports to ensure they meet quality standards, Standard Operating Procedures (SOPs), ICH-GCP guidelines, and protocol specifications. This includes reviewing documentation of findings and follow-up actions, identifying potential data quality or compliance issues, assessing their impact on study timelines, and escalating critical concerns with recommended solutions.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at Parexel? Share your experience