Parexelis in the business of improving the worlds 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 experiencedProject Leader or Senior Project Leader'to lead project delivery and oversight to ourBiotechclientsand their projects on a global level. You will ideally have Therapeutic Area expertise in a combination of the following:Oncology,Ophthalmology, Neurology or Dermatology.
This position is available in the following EMEA locations -UK, Ireland, Poland, Romania, Italy, Spain, France, Serbia, Hungary, Czech Republic, Netherlands, Lithuaniaand we offer fully remote (country stipulated), hybrid or office-based working.
As theSenior Project Leader (Senior Clinical Project Manager)you will actively lead theParexel 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 beingcompliant 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 PL:
-Manage the project according to budget with revenue recognition and forecasting, including resource management, pass-through management (review, regular reconciliation and forecasting).
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:
- Bachelors 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 strongclient 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 eitherEarly Phase and/or Phase II-III clinical project managementwith demonstrableproject leadershipskills are essential.
- In-depth knowledge in any therapeutic areas (TA's) are welcome. There is a strong preference for a combination of the following areas due to our current resource needs:Oncology,Ophthalmology, Neurology or Dermatologytherapeutic expertise.
- Strong command of written and spoken English language is essential. An additional language is a benefit.
- PreviousCRO experience is strongly preferredwith involvement inbid defense activities.
- Strongfinancial managementandclient relationshipskills 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.
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