Clinical Research Manager - FSP
Czechia, Remote Job ID R0000025609 Category Clinical TrialsAbout this Role
Key Accountabilities:
Project Initiation & Planning:
Manage study start-up activities
Provide input to project tools, PM 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 within a given program
Develop study plans, tools and forms.
Project Implementation, Control & Evaluation:
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 productivity targets to project team members
Provide performance feedback on team members as appropriate
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
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 instigate process improvements within the project
Provide input to the Revenue Recognition forecast
Identify changes in scope and liaise with Project Leader
May be required to conduct site visits as per client or project demands
Participate in client, investigator and team meetings
Prepare, participate in and follow up on audits / inspections
Participate in all required applicable trainings
Project Close-out:
Collaborate with project team (e.g. Project Leader and Data Operations Leader) on database lock activities
Together with Project Leader ensure all administrative closeout procedures are completed according to Project Close-out Checklist
Together with Project Leader ensure project is archived and all documentation returned to the client 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)
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
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
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
#LI-REMOTE
JOBS FOR YOU
There is no jobs to view
You currently have no saved jobs to view.
Make sure to accept the Functional cookies to enable this module to display saved job links. You will be able to review them here when you revisit this page..
More Than A Job
