United States-, Clinical Operations Leader (CTM/CPM) - HOME BASED post_00023855-MZ
|PAREXEL currently has excellent opportunities for Clinical Operations Leaders with background in leading clinical trials in a variety of therapeutic areas . These positions can be regionally home based anywhere in US. The individuals selected for these roles will provide leadership and oversight to the clinical team and manage the day to day clinical operations of domestic and international projects. The Clinical Operations Leader is responsible for coordinating the functional team members and their activities, liaising with project leadership and the sponsor to ensure that deliverables (timeline, quality, productivity) are met. The Clinical Operations Leader has overall accountability for the execution of the clinical operations strategy on the project. The Clinical Operations Leader ( COL), may act as Project Leader for projects involving a small number of services, where no Project Leader is assigned. |
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 & Planning
Manage study start-up activities, in small size studies
Provide input to project tools, PL project plan, Central File Maintenance Plan
Provide input to the format and content for sponsor reports
Provide input to and oversight of site selection strategy plan
Develop site selection and monitoring plans for the team
Review and provide input into patient recruitment plan and retention plan
Ensure all team members have access to tools and documents
Establish efficient / effective working relationships with other functional Leaders and coordinators across geographies and projects within a given program
Develop study plans, tools and forms.
Evaluate and identify resourcing needs and continuously monitor over life cycle of project
Address identified and escalated site issues and drive to closure
Early recognize 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
Oversee maintenance and quality check of Central Files
Participate in client, investigator and team meetings
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)
QualificationsSuccessful candidates must possess substantial work experience leading clinical trials across functional groups within a CRO of Pharmaceutical environment. The position requires prior onsite monitoring experience and candidates that are detailed-oriented, computer proficient in a Windows environment and possess superior interpersonal and organizational skills. This role also request a degree in life science, nursing qualification or relevant experience.
EEO DisclaimerPAREXEL complies with all applicable federal, state, and local laws prohibiting discrimination in employment. All qualified applicants will receive consideration for employment without regard to gender, age, race, color, religious creed, marital status, sexual orientation, national origin, ethnicity, ancestry, citizenship, genetic information, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.
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