Description
Here at Syneos Health, we are looking for a Global Project Manager to work sponsor dedicated. You will have the chance to work in exciting studies in various therapeutical areas. The job location is Home Based.
Purpose Of The Role
The Clinical Trial Leader (CTL) is a key member of Clinical Delivery Team nominated to a specific trial within the Evidence Network.
The CTL provides leadership and direction to the trial team (core and extended team members) and is accountable for the overall success and delivery of their assigned clinical trial according to defined milestones and key performance indicators. They are responsible for steering and directing clinical trial activities, including patient and site engagement activities, direct communication and interaction with multiple internal and external stakeholders (e.g. investigative sites) and team members on a global, multi-country or regional basis.
The CTL is responsible for managing the planning, implementation, and tracking of the clinical trial process as well as risk mitigation. The CTL serves as a proactive member of the clinical delivery team, liaising closely with the Clinical Trial Managers (“CTM”) on all study-related issues. As leader of the Trial Team, the CTL communicates trial status to stakeholders, escalating issues as appropriate. **
Main Accountabilities**
Trial Preparation
- Accountable for the accurate planning and operational feasibility of trial timelines; and oversight of trial preparation to ensure trial team members are aligned and on track. Supports development of trial level documents owned by other functions (e.g. Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring).
- Verifies and provides input into the country allocation and oversees trial feasibility.
- Accountable for development and implementation of trial level engagement plans, recruitment planning and risk mitigation. Leads development of core trial and patient facing documents. Integrates patient/site level feedback during document development and ensures trials are designed with a focus on patient value.
- Ensures activities are frontloaded where possible at the trial level and cascaded to country level to facilitate efficiencies as well as to ensure and leverage speed.
- Oversees outsourcing of vendor services in conjunction with other functions. Supports identification of vendors, vendor selection and development of vendor scope of work.
- Works with functional partners to ensure that all required trial processes are in place to meet trial delivery milestones (e.g. clinical quality monitoring, safety monitoring and reporting, investigational medicinal product, trial budget, site monitoring).
- Aligns and supports team members in timely responses to questions from Regulatory Authority/Ethics Committee and other external stakeholders.
Trial Conduct
- Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring/mitigation. In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, SMC/DMC management and safety reporting.
- Prepare and implement amendments of core documents including training material updates/retraining as needed.
- Support authority/ethics responses to requests as applicable.
- Maintains oversight of outsourcing of vendor services (including central lab) in conjunction with other functions.
- Monitor progress of patient recruitment and accrual of endpoints and proactively update and action contingencies throughout trial conduct.
- For early clinical trials, co-ordinates and harmonizes Innovation Unit tasks in a trial (e.g. biomarker sampling, genomics, sub-studies).
Trial Closeout and Reporting
- In collaboration with other functions, ensures timely cleaning and delivery of clinical trial data. Coordinates and supports Trial Medical Writer in providing the CTR.
- Responsible for timely, complete and compliant archiving of all relevant global documents in the TMF, including all required documents from vendors.
- Support results/documents disclosure of global registries
- May support publication of trial data.
Qualifications
Qualifications:
Degree /education
Requires a university degree (e.g. Masters degree or comparable degree), with extensive experience in clinical trial project management in an international context. Major focus: Biomedical Life Sciences **
Required Capabilities**
- Strong Communication Skills: Demonstrates AAI approach and skills in complex cross-functional matrix structures of the trial and extended team. Articulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and action. Demonstrates active listening skills and cultural awareness.
- Scientific and Operational Expertise: Demonstrates scientific and therapeutic knowledge and operational expertise across all aspects of clinical trial planning and execution. Dimensions of trial complexity include protocol, patients, sites, countries, vendors.
- Leadership and Influence: Demonstrates skills and capabilities in addressing complex situations, confidently setting direction for teams. Demonstrates leadership behaviours of supporting, connecting and empowering teams, providing future direction, demonstrating visionary and innovative thinking and inspiring teams to achieve a common goal. Executes activities with a clear aim to deliver value to patients.
- Strategic Mindset: Strategic and visionary thinker who is future focused, creative, courageous and able to navigate through ambiguity. Integrates study strategy with overall TA portfolio. Embraces cross functional initiatives, applying innovative learnings. Is results-oriented with a global mindset using analytical thinking to provide risk-balanced solutions.
- Coordination and Oversight: Collaborative leader who demonstrates skills and capabilities in setting priorities, managing pace of activities, and efficient usage of resources.
- Project Management: Plans effectively, setting priorities, and defining actions. Makes effective use of resources, and proactively strives for transparency and clarity to accomplish the business deliverables. Translates complex situations to actionable parts. Anticipates and resolves challenges and translates learnings to new projects. Takes smart risks.
Benefits
- Competitive remuneration package with excellent benefits
- Commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization
- Opportunity to work within a successful and rewarding environment
Are you interested?
If you are interested in this role and you believe you would be the right fit, we would be more than happy to hear from you. You can apply online.
To find out more about our company and search and apply for other open jobs please visit our website https://www.syneoshealth.com/ **
About Us**
Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 24,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. **
Disclaimer**
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
