[Hiring] Clinical Operations Leader @Parexel

Role Description

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.
  • 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 monitor for changes in scope.
  • Monitor cost drivers and actively seek 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.

Qualifications

• 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.

Requirements

• 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.