Clinical Trial Manager- Fsp

**Primary Location**: Singapore

**Job ID** R0000035100

**Category** Clinical Trials

**ABOUT THIS ROLE**:
**Key Accountabilities**:
**Client 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 & 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 prob