Biotech Project Leader (up to Senior level)

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Lead the Parexel and Client teams by combining deep clinical research experience with insight into client pressures in order to develop the right solution for the client. This requires in-depth project management skills and business understanding, knowledge, and experience in order to independently make effective decisions and take action.
This role provides the overall cross-functional leadership of medium to high complex clinical trials or low complex clinical trial programs as well as the project teams to achieve operational excellence and deliver projects/programs on time, to budget, to the highest quality, compliant with ICH GCP, and that meet client expectations. This position is responsible for the profitability of a project(s) and client satisfaction.
The Senior Project Leader acts as a role model and/or mentor for the team and Project Leaders. Senior Project Leaders may support program management responsibilities, if requested. Senior Project Leaders may mentor junior staff and Functional Leads for specific projects. This position is expected to be able to lead a global study team without any major guidance.

This is Biotech Project Leader opening.

Based on the level of experience, may consider up to Senior Project Leader level.

Key Accountabilities:

Independently responsible for all Project Leader tasks and deliverables according to SOPs on assigned projects including:

• Develop and maintain a formal project plan or co-develop program level guidance / manuals with all key milestones, budgets, and resources assigned to specific tasks and outcomes.
• Define metrics for reporting performance against plan.
• Ensure that all standard project systems and tools are set up correctly and functioning appropriately.
• Implement operational strategy as defined in the project plan and makes changes to the plan to ensure desired results. Proactively solve problems in collaboration with the client and project team. Seek advice / approval from Project Director or Director, Project Leadership, as, and when, required.
• Close out of all project activities upon project completion; perform financial reconciliation and system closeout. Identify best practices developed during project and share lessons learned across the organization.

Perform initial and ongoing risk management:

• Identify potential project (or program) risks and implement contingency plans, mitigate actual risks with team members and keep client informed about risks and contingencies.

Manage and ensure first time quality on the project deliverables:

• Establish quality standards for the project (or program) that drive individual and team commitment to quality. Monitor quality of deliverables and implement corrective and preventative action as needed.

Develop and manage the client relationship:

• Owns the client relationship at a study level and responsible for client communication ensuring high client satisfaction.
• Establish effective channels and standards of communication among all key stakeholders that supports timely and efficient delivery of the information required for the effective completion of the project.
• Pro-active approach to providing solution set for clients in a timely manner.
• Actively seek support in managing disagreements and communicating concerns

Understand and own the project P&L:

• Manage the project according to budget with revenue recognition and forecasting, including resource management, pass-through management (review, regular reconciliation and forecasting) and managing Change in Scope in collaboration with the Project Specialist, the Client Contract Manager, the Project Financial Business Partner and functional leaders. Handle all project invoicing activities.

Manage the cross-functional project team:

• Enable all stakeholders to achieve successful study completion while maintaining high client satisfaction. Establish team goals, inspire individual ownership, and establish processes to support project result accountability. Lead internal monthly project review meetings.
• Ensure relevant project (or program) specific training is developed and followed as required

Represent Project Leadership function:

• Represent Project Leadership Function in external client meetings and presentations such as Bid Pursuit Meetings, Investigator Meetings or others as required. May represent PAREXEL at professional meetings / conferences.

Other assigned responsibilities:

• May include non-billable work such as SOP review and lead or contribute to other organizational initiatives.

Skills:

• Ability to create a sense of urgency and take a proactive, solutions-based approach
• Strategic Thinking skills
• Conflict Management skills
• Excellent interpersonal, verbal and written communication skills
• Highly accountable
• Client focus
• A flexible attitude with respect to assignments and new learning; leading by example
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• Ability to thrive in a matrix environment and to value the importance of teamwork
• Thorough understanding of all aspects of project life-cycle
• Ability to work independently with minimal oversight guidance
• Ability to analyze complex/novel situations and develop nonstandard solutions
• Proficient in Microsoft Excel, Power Point, and Word, and project planning software
• Ability to become proficient with PAREXEL systems
• Familiarity with standard business and eClinical systems used in Clinical Research – such as CTMS, EDC, IXRS, TMF and project planning tools
• Proficient in ICH and GCP regulations in relevant geographies
• Solid clinical knowledge and relevant understanding of clinical research and protocol design
• Ability to adopt and work according to PAREXEL High Performance Culture (HPC) principles
• Ability to inspire cross-functional teams to collaborate and demonstrate ONE PAREXEL approach
• Competencies aligned to Project Leadership Job Models for: Project Planning; Project Execution; Project Fulfillment; Financial Management; Risk Management; Quality Management; Team Leadership; Communication and Relationship Management

Knowledge and Experience:

• Strong command of written and spoken English language, local language proficiency as required
• Proven advanced project management experience, preferably in healthcare, clinical research, or contract research organization
• Proven track record of developing client relationships at project level
• Different trial phase experience will be an advantage
• At least 10-12 years or more experience in clinical trials with 3 years (minimum) in project management from local (AUS/ NZ experienced candidates) is required.

Education:

• Bachelor’s degree in a science/medical related field. Advanced degree desirable
• PMP or equivalent desirable