Clinical Project Leader (Phase IIIb/IV) - home-based U.S and Canada - The Brady Group

Position Description

Lead the COMPANY and Client teams by combining a depth of clinical research experience with insight in to client pressures and an ability to develop the right solution for the client. This requires in-depth business understanding in order to make effective decisions independently and the knowledge and experience required to confidently recommend a course of action where client intervention is required. This includes providing the overall leadership of clinical trials or clinical programs and the project teams to achieve operational excellence; and delivering projects / programs on time, to budget, to the highest quality, compliant with ICH GCP, exceeding client expectations. This position is responsible for the profitability of a project(s) and client satisfaction.

Role Summary:
The primary role of the Project Leader is to lead and manage domestic or international projects. May be part of a global project management team. Requires some interaction/supervision by Line Manager or Senior Project Leader or Director. Project Leaders may mentor junior staff and Functional Leads for specific projects. Project Leaders participate in proposal development teams, giving input to particular indication and operational structure for the proposal. Project Leaders are responsible to represent Project Management at marketing/new business meetings.
General areas of responsibility include: Sponsor liaison, project assessment and initiation, resource procurement and planning, project implementation, leading and motivating a cross-functional team, milestone planning and tracking, ensuring that projects are progressing according to contract and quality standards, SOPs, ICH-GCP and/or other guidelines to fulfill local regulations, production of key project progress reports, management of communication between COMPANY project team, Sponsor, contract and financial management.

Client Liaison
’ Owns the client relationship and responsible for client communication ensuring high client satisfaction. Pro-active approach to providing solution set for clients.

Project Initiation & Planning
’ Lead client kick off meeting and discussion with client, by establishing client expectations for project delivery, communication, and client specific metrics. Ensure the scope of the study is well understood by the project team and set the team expectations.
’ Lead a formal hand over meeting with Account Management, CRD/DPM, Business Operations and assigned Project Analyst and Project Specialist to understand the scope of the contract and any Master Services agreement (MSA) in place for the client.
’ Review the project contract exhibit and ensure relevant Functions have received it.
’ Manage the set up of the project team overseeing request for resource provided by Project Analyst, reviewing proposed team members for suitability and managing any project team changes throughout the duration of the project.
’ Work with the Project Specialist, on developing a project plan including all elements listed in the project plan template as appropriate for the project (Roles and Responsibilities, WBS, MSP, Communication Plan, Risk Analysis, etc).
’ Review initial budget split provided by Project Analyst, request for study specific adaptations.
’ Review and finalize project metrics with Project Analyst and Project Specialist.
’ Lead the team kick-off meeting, ensure the scope of the study is well understood by the project team and all functions and that the appropriate resourcing will be delivered by the functions.
’ Lead the discussion of Client and Functional Leads concerning study/Client specific metrics and how these can be collected.
’ Ensure that study specific management tools and Central File Maintenance plan are in place.
’ Work with the Project Specialist to set up project-related training as needed for team members.
’ Initiate the project following review of Lessons Learned to ensure current Best Practices are implemented.
’ Work with the team to coordinate internal and external user acceptance review of the EDC system.

Project Implementation, Control & Evaluation
’ Lead the project such that it is completed within budget, schedule and according to contract specifications.
’ Ensure the project is progressing according to quality standards, SOPs, ICH-GCP and/or other guidelines to fulfill local regulations.
’ Ensure information entered into management systems (e.g., PERFORM, GXDB, etc.) is accurate and updated on a regular basis.
’ Use project plan as a management tool to record, measure and manage progress.
’ Work with Project Specialist and Project Analyst to develop ‘what if’ scenarios to enable pro-active decisions and solutions.
’ Proactively take action where required to maintain project deliverables using management information provided by the Project Specialist and Project Analyst (e.g., compliance to site and patient enrollment plans).
’ Use management reports prepared by the Project Analyst and Project Specialists to effectively manage the project’s critical path, resourcing, metrics compliance, the budget and third party vendors.
’ Gather feedback from Functional Leads on deviations of metric collection and actions taken to resolve deviations.
’ Gather feedback from Project Analyst on deviations of resources and time spent to evaluate project progress and profitability; identify CIS (changes in scope) in a timely manner.
’ Take primary responsibility for the responses and corrective actions to project audit findings.
’ Manage the project budget with the Project Analyst including the completion of monthly revenue recognition, forecasting and cost management.
’ Lead the project pro-actively, anticipating problems and providing resolutions in a timely manner.
’ Pro-actively communicate with the client ensuring the client has all the information required on project progress and status (risk analyses, contingency plans, technical information, significant changes of any kind etc); provide pro-active decisions /solutions and how the project objectives are being, or should be, achieved.

Communication
’ Proactively identify and communicate project team and client team roles and responsibilities to client and their affiliates, as appropriate.
’ Lead team meetings on a regular basis with project team to ensure project objectives are met; ensure the on-going communication to team members of the scope of work, timeline and project goals, technical information, and input from client throughout the project including significant changes in resourcing, scope of work and timelines.
’ Lead regular meetings/calls with client to ensure they are fully informed of project progress, pro-active decisions / solutions and how the project objectives are being achieved.
’ Communicate to Line Manager any needs or concerns regarding level of training or performance of any team member.
’ Provide Line Manager with input regarding team members’ performance as needed for employees’ periodic performance review.
’ Work with team to prepare and update project plans, project status and other administrative reports and submit to clients as required by the contract exhibit, and other internal stakeholders (e.g., update of GXDB including comment section).
’ Communicate fiscal, contractual, resource, deliverable and client-related issues to Portfolio Director as appropriate.

Project Close-out
’ Oversee all administrative closeout procedures are completed, according to Project Closeout Checklist.
’ Ensure project is archived and all documentation returned to the client as specified the by the contract.
’ Lead end of study meeting to ensure lessons learned information is documented and passed on via appropriate channels.

Skills
’ Critical Thinking & Problem Solving
’ Financial Management skills
’ Strategic Thinking skills
’ Conflict Management skills
’ Consulting skills
’ Contingency Planning & Risk Management skills
’ People Management skills
’ Excellent interpersonal, verbal and written communication skills
’ Client focused approach to work
’ 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
’ Proficient in local language and profound working knowledge of the English language
’ Proficient in Microsoft Excel, Power Point, MS Project and Word.
’ Experience with COMPANY systems
’ Willingness to work in a matrix environment and to value the importance of teamwork.
’ Travel is a requirement of this job.

Education
’ Bachelor’s degree in a science related field, with an advanced degree desirable
’ PMP or equivalent desirable

Minimum Work Experience
’ Proven relevant experience in healthcare, clinical research, project management or contract research organization.
’ Peri-approval study phase experience necessary with large scale post-marketing, EAP and/or remote monitoring trials. Experience working with research-naive sites and in providing creative solutions to Sponsor organizations in the post-marketing area.

How to Apply

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