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. At Parexel FSP people make a difference. We have a crucial mission: to prevent and cure disease by delivering important new medicines and therapies to patients in need. We achieve this important goal through the knowledge, expertise, innovation, and commitment of our employees around the world. You will play a key role in supporting, coordinating, and conducting local, very sophisticated, oncology clinical trials for our client, a top 10 Pharma business. This includes full involvement in study start-up, maintenance, and closure, as well as vendor management and CRA oversight. The Clinical Research Manager (CRM) is primarily accountable for end-to-end performance and project management for assigned protocols in compliance with International Committee on Harmonization (ICH) / Good Clinical Practice (GCP) and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally. This will be a home-based position, but some occasional travel may be required. Key Accountabilities: Client Liaison: Effectively communicate with internal and external customers as well as third party vendors. Prioritize effectively and respond to urgent requests within team or from sponsor. Project Initiation & Planning: Manage study start-up activities. Provide input to project tools, PM plan, Central File Maintenance Plan, and oversight of site selection strategy plan. Develop site selection and monitoring plans for the team. Review and provide input into patient recruitment plan and retention plan. Develop study plans, tools, and forms. Project Implementation, Control & Evaluation: Provide leadership and direction to project team members. Evaluate and identify resourcing needs and continuously monitor the use of resources over project life cycle. Address identified and escalated site issues and drive to closure. Monitor study timelines, patient recruitment, retention, and data cleaning to ensure successful outcome of the project. Maintain and assure quality of work generated and escalate and follow up as appropriate. Implement and instigate process improvements within the project. Provide input to the Revenue Recognition forecast. May be required to conduct site visits as per client or project demands. Project Close-out: Collaborate with project team (e.g., Project Leader and Data Operations Leader) on database lock activities. Together with Project Leader ensure all administrative closeout procedures are completed according to Project Close-out Checklist, project is archived, and all documentation returned to the client as specified by the contract. Participate in end of study meeting and give input to lessons learned information and feedback relevant information into the relevant functions. Skills: Leadership skills that include: Ability to lead a virtual team across locations and cultures. Ability to negotiate and influence with diplomacy in order to achieve results, and to make decisions even in ambiguous situations to achieve project timelines and quality. Ability to conduct root cause analysis in business problem solving and process improvement development. Strong customer focus, ability to interact professionally within a client organization. Effective time management in order to meet daily metrics or team objectives. Personal skills that include: Ability to take initiative and work independently and within a team. Commitment to high quality work and respective consistent performance Excellent interpersonal, oral, and written communication skills Excellent presentation and consulting skills. Business / operational skills that include: Customer focus and commitment to delivery and quality. In-depth understanding and experience in the clinical trial process and understanding of all aspects of project life cycle. Knowledge of SOPs/guidelines, ICH-GCP and other applicable local and international regulations. Knowledge and Experience: Strong command of written and spoken English language. Proven clinical experience or management experience in healthcare, clinical research, or contract research organization. Substantial experience in clinical research including relevant experience as a team Leader in Clinical functions or proven experience in coordinating clinical trials. Education: Degree in a life science, nursing qualification or relevant clinical and or clinical management experience. If you are a professional with experience in leading clinical trials and have previously worked as a CRA, as well as holding a solid background in project management or people management, we can offer you a stellar future. A future that will not only involve you in developments of international importance for a renowned sponsor but will also prepare you for project management and other high-level roles. Not quite the role for you? Join Our Talent Community and we’ll reach out with job alerts when positions that match your career interests become available. We’ll also share periodic updates about the latest company news and events. Sign up today https://jobs.parexel.com/functional-service-provider Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.