Clinical Research Manager - FSP

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