Clinical Trial Manager-FSP

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

Support overseeing and / or managing study start-up activities, as applicable

Provide input with LM consultation/support to:

• project tools and study plans the format and content for sponsor reports / templates if applicable
• Provide input to and oversight of site selection strategy plan with LM consultation/support and under guidance of Clinical Operations Leader.
• Support development of site selection and monitoring plans with LM consultation/support
• Review and provide input into patient recruitment plan and retention plan
• Assist with ensuring all team members have access to study systems, tools and documents
• Establish efficient / effective working relationships with other Functional Leaders
• Support development of study plans, tools, forms, templates pertaining to Clinical Operations

Work with Clinical Operations Leader to 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

Provide input to identifying, organizing and delivering (where appropriate) study specific training in collaboration with Clinical Operations Leader, Project Leader and Project Specialists

• Support evaluating and identifying 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
• Support early recognition of areas of potential problems and provide input to contingency plans
• Monitor study timelines, patient recruitment, retention and data cleaning to ensure successful outcome of the project
• Assist the Clinical Operations Leader in liaising with vendors to support clinical activities
• Support overseeing 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
• Support implementing and proactively initiating process improvements

Provide input to the Revenue Recognition forecast

• Identify changes in scope and liaise with Clinical Operations Leader and/or Project Leader
• May be required to conduct site visits as per sponsor or project demands
• Participate in sponsor, investigator and team meetings as appropriate
• 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 Operations Leader) on database lock activities Together with Clinical Operations Leader and Project Leader ensure all administrative closeout procedures are completed according to Project Close-out Checklist Together Clinical Operations Leader and with Project Leader ensure project is archived and all documentation returned to the client as specified by the contract May participate in end of study meeting and give input to lessons learned information and feedback relevant information into the relevant functions Together with the Clinical Operations Leader and Project Leader ensure project is archived and all documentation returned to the sponsor as specified by the contract May 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 procedures

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.

Skills:

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 results

Ability to make decisions even in ambiguous situations to achieve project timelines and quality  Ability to proactively identify and solve problems by using a logical, systematic approach

• Ability to conduct root cause analysis in business problem solving and process improvement development
• Strong customer focus, ability to interact professionally within a client organization
• Ability to manage multiple and varied tasks with enthusiasm, prioritize workload with attention to detail
• Effective time management in order to meet daily metrics or team objectives
• Ability to conduct root cause analysis in business problem solving and develop process improvements
• Strong customer focus, ability to interact professionally within a sponsor organization
• Ability to manage multiple and varied tasks with enthusiasm, prioritize workload with attention to detail
• Effective time management in order to meet daily metrics or team objectives

Personal skills that include:

• Ability to take initiative and work independently
• Ability to successfully work in a team environment
• Sense of urgency in completing assigned tasks
• Commitment to high quality work and respective consistent performance
• Excellent interpersonal, oral and written communication skills
• Ability to gain trust and confidence with a client as well as within PAREXEL
• Good learning ability
• Action oriented
• Good presentation skills
• Good consulting skills
• A flexible attitude with respect to assignments and new learning
• Ability to travel as required
• Business / operational skills that include
• Customer focus
• Commitment to first-time quality and consistent performance
• Proactive issue identification and resolution
• In-depth understanding and experience in the clinical trial process and understanding of all aspects of project life cycle
• Knowledge of SOPs/guidelines, ICH-GCP and other applicable local and international regulations

Ability to become proficient with Parexel systems

Proficient computer and internet skills including knowledge of MS-Office products such as Excel, Word, Power Point, Outlook, Webex, MS Teams and other collaboration platforms

Knowledge and Experience :

Strong command of written and spoken English language, local language proficiency as required Relevant work experience - CRA experience or minimum substantial relevant experience (preferably on-site monitoring experience) “Coordinating experience”: Preferably obtained while working in a Sr. CRA or in-house CRA position

Substantial experience in clinical research in clinical functions. Individuals should have potential to understand cross-functional activities related to data processing, cleaning and site management

Individuals should have a strong understanding of cross-functional activities

Education:

• Degree in a life science, nursing qualification or relevant clinical and or clinical management experience
• Originally posted on Himalayas