PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.
Post: Project Leader / Senior Project Leader
Job Description:
Essential Function
Lead the PAREXEL 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 recommending 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 and therefore acts as a role model and/or mentor for the team.
Role Summary:
The primary role of the Senior Project Leader is to lead and manage domestic or international projects and may oversee a series of small programs on a particular compound. May be part of a global project management team. Requires minimal interaction/ supervision by Line Manager or Senior Project Leader or Director. Senior Project Leaders may mentor Associate Project Leaders 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. The Senior Project Leader will support Leadership by developing ways to align people's contribution to business goals and strategic thinking and developing a mentoring and learning behavior for Project Leaders.
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 PAREXEL project team, Sponsor, contract and financial management.
Key Accountabilities
Client Liaison
- Owns the client relationship and responsible for client communication ensuring high client satisfaction. Pro-active approach to providing solution set for clients.
- Seeks out opportunities to leverage the relationship for future sales.
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, DPM/Portfolio Director(s), P&C and assigned Project Financial 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 Financial 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 Financial Analyst, request for study specific adaptations.
- Review and finalize project metrics with Project Financial 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 based on approaches that have been successful with other projects including the analysis of best practice approaches of competitors.
- 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 Financial 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 Financial Analyst (e.g., compliance to site and patient enrollment plans) while maintaining a focus on quality of deliverables in order to manage client expectations...
- Use management reports prepared by the Project Financial 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 Financial Analyst on deviations of resources and time spent to evaluate project progress and profitability; identify CIS (changes in scope) in a timely manner.
- Take and demonstrate primary responsibility for the responses and corrective actions to project audit findings.
- Manage the project budget with the Project Financial Analyst including the completion of monthly revenue recognition, forecasting and cost management.
- Lead the project pro-actively, anticipating obstacles and providing resolutions (e.g. contingency plans) in a timely manner before they impede the ability to reach the goals.
- 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.
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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.
- Capitalize on the diverse background and viewpoints to increase the productivity of the group.
- 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 channel.
Candidate Profile:
Experience:
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 PAREXEL 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 substantial relevant experience in healthcare, clinical research, project management or contract research organization.
- 5 years clinical trial experience
- 2 yrs project management experience is preferred
Additional Information:
Location: India - Maharashtra - Mumbai
Industry Type: Pharma/ Biotech/Clinical Research
Deptt.: Project Management
Functional Area: QA
End Date: 29th June, 2012
Job Id: 2609104
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