Project Leader / Senior Project Leader - Biotech (Select EU countries)

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.

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the world transform scientific discoveries into new treatments. We believe in our values, Patients First, Quality, Respect, Empowerment & Accountability.

We are currently looking to recruit an experienced Project Leader or Senior Project Leader to lead project delivery and oversight to our Biotech clients and their projects on a global level. You will ideally have Therapeutic Area expertise in a combination of the following: Oncology plus any of the following Dermatology, Women's Health, Neurology, Rare Disease or Radiopharmaceuticals .

This position is available in the following EMEA locations - UK, Ireland, Poland, Romania, Spain, Hungary, Croatia, Lithuania and we offer fully remote (country stipulated) home based working.

As the Clinical Project Leader or Senior Project Leader (Clinical Project Manager) you will actively lead the Parexel and client teams by combining your deep clinical research experience with insight into client pressures in order to develop the right solution for the client.

You will provide overall cross-functional leadership of our clinical trials and studies as well as the project teams to achieve operational excellence and deliver projects on time, to budget, with the highest quality as well as being compliant with ICH GCP to meet client expectations.

Key Accountabilities:

• Independently responsible for all Project Leader tasks and deliverables according to SOPs on assigned projects:
• Develop and maintain a formal project plan with all key milestones, budgets, and resources assigned to specific tasks and outcomes.

Perform initial and ongoing risk management:

• Identify potential project 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 that drive individual and team commitment to quality.

Develop and manage the client relationship:

• Owns the client relationship at a study level and responsible for client communication ensuring high client satisfaction.

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) as well as managing Change in Scope and all all project invoicing activities.

Manage the cross-functional project team:

• Enable all stakeholders to achieve successful study completion while maintaining high client satisfaction.

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.

Other assigned responsibilities:

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

Education:

• Bachelor’s degree or equivalent level of education (Science or Medical related field preferred) or proven substantial clinical project management experience.
• Advanced degree desirable.

Skills :

• Ability to take a proactive, solutions-based approach.
• Critical thinking & problem-solving.
• Excellent interpersonal, verbal and written communication skills.
• Highly accountable with a strong client focus.
• A flexible attitude with respect to assignments and new learning.
• Ability to manage multiple and varied tasks with enthusiasm and be able to prioritize workload with high attention to detail.
• Ability to work in a matrix environment and to value the importance of teamwork and collaboration.
• Basic understanding of all aspects of the project life cycle.
• Ability to work independently with oversight guidance.
• Proficient in Microsoft Excel, Power Point, and Word, and project planning software.

Knowledge and Experience:

Strong previous CRO experience and understanding of Phase I, II-III clinical trial project management with demonstrable project leadership skills are essential.

In-depth knowledge of the Therapeutic Areas due to our current resource needs: Oncology is essential plus any of the following Dermatology, Women's Health, Neurology, Rare Disease, Radiopharmaceuticals are desirable.

• Strong command of written and spoken English language is essential.
• Strong financial management and client relationship skills as well as involvement with bid defense activities are essential.
• Applications from candidates with pharma experience may also be considered.
• Familiarity with standard business and eClinical systems used in Clinical Research is desirable.
• ICH and GCP regulations in relevant geographies.
• Solid clinical knowledge and understanding of clinical research and protocol design.

In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive salary, bonus, (car allowance is country specific) and a benefits package including holiday, pension and other leading-edge benefits that you would expect with a company of this type.

• Apply today to begin your Parexel journey!
• Originally posted on Himalayas