The Manager is responsible for the oversight of a team or group. This includes ensuring successful performance and delivery of his/her direct report’s project deliverables, on time with high quality. The Manager is responsible to resource client projects with suitably developed professionals and to retain and develop these professionals within PAREXEL. The Manager may also be part of a project team and be responsible for successful delivery of his/her own project deliverables, on time with high quality. The Manager is responsible to promote new business by participating in project bids and client presentations
as appropriate. The Manager is responsible to provide clinical consultation to project teams as needed.
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.
Manage study start-up activities
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
Support development of site selection and monitoring plans for the team
Review and provide input into patient recruitment plan and retention plan
Assist with ensuring that 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
Support development of all study plans, tools and forms.
Provide leadership and direction to project team members
Provide input to identifying, organizing and delivering (where appropriate) study specific training in collaboration with Project Leader and Project Specialists. If Clinical Manager has concerns about CRA’s/CMA’s/CTS’ intelligibility, CM may ask relevant project team member to train such CRAs/CMAs/CTSs.
Evaluate and identify resourcing needs and continuously monitor overlife cycle of project
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
Support early recognition of 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
Support overseeing 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
Support implementing 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/remote visits or site contacts as per client or project demands in case that assigned CRA is not appropriate person or not available.
Participate in client, investigator and team meetings
Prepare, participate in and follow up on audits / inspections
Participate in all required applicable trainings
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 withProject Leader ensure project is archived and all documentation returned to the client as specified by the contract
May participate in end of study meeting and give input to lessons learned information and feedback relevant information into the relevant functions
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
good presentation skills
good consulting skills
flexibility to change
ability to travel as required
Business / operational skills that include:
customer focus
commitment to high quality work and respective consistent performance
proactive issue identification and resolution
provision of win-win solutions to problems
in-depth understanding and experience in the clinical trial process
knowledge of SOPs/guidelines, ICH-GCP and other applicable local and international regulations
proficient computer and internet skills including knowledge of MS-Office products such as Excel, Word, Outlook and Windows.
People management skills that include:
Demonstrated ability to successfully manage a full workload across multiple-projects.
Ability to manage and motivate direct reports
Excellent interpersonal, verbal and written communication skills (including experience in making presentations at conferences, meetings, training sessions)
A flexible attitude with respect to work assignments and new learning
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
Ability to work in a matrix environment and to value the importance of teamwork.
Excellent negotiation skills
Language Skills:
Competent in written and oral English and local language
Relevant work experience :
CRA/CMA experience or minimum substantial relevant experience (preferably on site monitoring experience)
“Coordinating experience”: Preferably obtained while working in a Sr. CRA or Sr. CMA position
Demonstrated ability to manage and motivate direct reports is required
Substantial experience in clinical research in Clinical functions. Individuals should have potential to understand cross functional activities related to data processing, cleaning and site management
Individuals should have a strong understanding of the cross functional activities
Degree level (biological science, pharmacy or other health related discipline preferred) or relevant clinical or business equivalent.
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