临床试验经理-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