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