Job type full-time
Full job description
Project manager in rare disease - sponsor dedicated - home based - (21013748) description
Project manager in rare disease - sponsor dedicated - home based
Come discover what our 25,000+ employees already know: work here matters everywhereWe’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the syneos health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the worldBecause to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
Why syneos health
#syneoshealthlife means we’re committed to our total self culture – where everyone can authentically be themselvesOur total self culture is what unites us globally, and we know every person’s unique contributions make a difference.
We believe our success is a direct result of the people who are driving it – you! we value your dedication to care for our customers and patients, so we want to focus on taking care of youThat’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
We are continuously building the company we all want to work for and our customers want to work withWhy? because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Creates and maintains the trial master file management (tmf) planRoutinely reviews the tmf to ensure quality, completeness and inspection readiness
Coordinates and monitors the activities associated with study deliverables across all applicable internal functional departments and vendors.
Assists with activities associated with interim analyses, database snapshots and locks, final csr and study closure
Assists with identification of and contracting with approved vendors, as necessary
Provides vendor management, inclusive of ensuring key deliverables are met, potential scope creep is identified and change orders are developed, as necessary
Assists with development and implementation of change orders
Assists with resource management and team member transition by collaborating with appropriate resource managers and ensuring detailed transition plans are developed and implemented efficiently
Develops contingency planning and risk mitigation strategies to ensure meeting or exceeding study milestones.
Creation and maintenance of metric reports, inclusive of data collection from multiple sources, for delivery to client or senior management
Assists with overall financial performance of the study by interacting with internal functional departments or vendors to obtain required metrics for financial reporting
Attends financial review meetings to assist with reconciliation and identification of budget overrun
Reviews and approves invoices from sites or vendors and to the client
Participates in representing the company to the client, ensuring satisfaction levels are met and statuses of deliverables are communicated effectively.
May participate in customer proposal development
In collaboration with the project team, will plan, coordinate and present at internal and external meetings
Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training
Develops knowledge of current therapeutic environment
What we’re looking for
Bachelor’s degree (or equivalent) level of qualification in life sciences, medicine, pharmacy, nursing or related field equivalent preferred
Prior experience in a contract research organization (cro), pharmaceutical, or biotechnology company preferredCro and relevant therapeutic experience preferred
Strong knowledge of good clinical practice/ich guidelines and other applicable regulatory requirements
Strong organizational skills
Strong ability to manage time and work independently
Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince and persuade
Flexibility and ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment
High level of competency in english language
Proficiency with ms office applications
Ability to travel as necessary (up to 25%)
Get to know syneos health
We are the only full-service biopharmaceutical solutions company in the worldThat means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it mostLearn more about syneos health.
Tasks, duties, and responsibilities as listed in this job description are not exhaustiveThe company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilitiesEquivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the job descriptionThe company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described aboveFurther, nothing contained herein should be construed to create an employment contractOccasionally, required skills/experiences for jobs are expressed in brief termsAny 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 employeesThe company is committed to compliance with the americans with disabilities act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Primary location: europe - fra-home-based
Job: clinical project management
Travel: yes, 25 % of the time
Employee status: regular