Clinical Operations Leader (PM)

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.

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 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
• Excellent 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 delivery and quality
• Proactive issue identification and resolution
• Provision of win-win solutions to problems
• 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
• Proven clinical experience or management experience in healthcare, clinical research, or contract research organization
• Substantial experience in clinical research including relevant experience as a team Leader in Clinical functions or proven experience in coordinating clinical trials. Relevant Work experience in clinical research
• Experience in Coordination of Clinical Trials – Preferably relevant working experience as an Associate Clinical Operations Leader or proven experience in a similar role
• Individuals should have a strong understanding of the cross functional activities

Education:

• Degree in a life science, nursing qualification or relevant clinical and or clinical management experience