Project Manager II, Sponsor Dedicated - Italy
- Experience Level
- Experienced (non-manager)
Here at Syneos Health, we are hiring a Project Manager II/ Senior Project Manager to be home based in EMEA or US and work sponsor dedicated to an innovative biotech on onco-heamatology studies. We are considering candidates from Italy, Spain, UK, France or United States.
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 22,000 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. A career with Syneos Health means your everyday work improves patients’ lives around the world.
The Project Manager II responsibilities are, but not limited to the below:
- Study oversight:
- Develop and maintain study project plan covering all study related activities/timeline tracking and review regularly with study team;
- Ensure timelines for design, build and release of production database are in alignment with First site activated;
- Ensure development of Data Management Plan - includes SDTM conversion, schedule for data transfers, data integrations, coding;
- Develop/Implement process for Site activation, IP release, kit delivery, systems access etc at time of Regulatory Green light;
- Establish monitoring requirements for monitoring plan. Oversight of Monitors/monitoring visit management/findings from visits;
- Ensure process are in place to Develop Country-Specific Informed Consent Form(s);
- Central IRB/EC Management and Oversight of Regulatory submission process timelines;
- Plan Operational Overview Meetings following feasibility, as required (coordinate slides, meeting planning, etc.);
- Contribute to Protocol development and review.
- Project planning;
- IP management;
- Vendor management;
The ideal candidate will need the following experience/skills to be considered:
Life Sciences Degree;
Must have clinical international/global project management with multi-country responsibilities (US would be a good plus);
Previous Onco-heamatology experience;
Very good knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements;
Demonstrated proficiency in problem solving, juggling multiple priorities and a commitment to quality and customer focus;
Proven ability to work independently in a fast-paced environment;
Strong communication, interpersonal, and organizational skills;.
Must demonstrate good computer skills;
Ability to provide clear direction and guidance to others;
Fluency in local languages and a high level of English language are required.
We have a comprehensive benefits package and offer highly competitive remuneration.
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.