Associate Clinical Operations Leader

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