Sr. Clinical Project Manager
- Employer
- Spark Therapeutics
- Location
- Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
- Salary
- Salary not provided
- Closing date
- May 11, 2022
View more
- Discipline
- Life Sciences, Biotechnology
- Job Type
- Project Manager
- Organization Type
- Pharma
Job Details
- Manage all clinical aspects of the clinical project including:
- Plan, execute and manage all aspects of multi-center global clinical trials in compliance with GCPs, SOPs, and within designated program budgets timelines and corporate goals;
- Lead the study team to manage risk mitigation strategies such as identify study level risks, develop, maintain and implement risk mitigation and contingency plans, and ensure key functional lines and senior management are informed
- A minimum of a Bachelor’ s degree in a scientific discipline or equivalent RN/BSN nursing degree (other majors considered with relevant work experience); advanced degree preferred
- Typically, 5-8 years of related global clinical trial conduct and operations experience and a thorough understanding of processes associated with project and study management, knowledge of GCP, site monitoring and clinical operations.
- Experience in operationalizing clinical trials in Rare Disease preferred (minimum of 1-2 years of recent experience).
- Demonstrated project management and leadership experience. Proven track record for delivering multi-center global clinical projects within time, budget, and quality expectations.
- ICH-GCP and FDA regulatory requirement understanding and competency.
- Strong clinical study management skills, including risk assessment and contingency planning.
- Ability to approach assigned duties in a highly organized, detailed and accurate manner.
- Ability to manage multiple priorities and work in a flexible, dynamic, and fast-paced environment.
- Ability to proactively identify, resolve and escalate issues
- Ability to lead and manage in a dynamic environment
- Excellent oral/written communication, organizational, problem solving and conflict resolution skills.
- Ability to lead cross-functional teams
- Ability (experience preferred) to work with cross-cultural teams including personnel from global locations as required per project with a positive attitude.
- Microsoft Project, Office, PowerPoint and Excel proficiency.
- Willingness to travel as dictated by assigned project requirements (approximately 25%). International travel may be required.
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
Nearest Major Market: Philadelphia
Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
We don't follow footsteps. We create the path.
Company
At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.
Founded in March 2013 as a result of the technology and know-how accumulated over two decades at Children’s Hospital of Philadelphia (CHOP), our investigational therapies have the potential to provide long-lasting effects, dramatically and positively changing the lives of patients with conditions where no, or only palliative, therapies exist. Greater understanding of the human genome and genetic abnormalities have allowed our scientists to tailor investigational therapies to patients suffering from very specific genetic diseases. This approach holds great promise in developing effective treatments to a host of inherited diseases. Our initial focus is on treating orphan diseases.
Headquartered in dynamic Philadelphia, we are a diverse, experienced team united in our goal to break down barriers for people and families affected by genetic diseases. As our name suggests, our investigational, one-time therapies are designed to spark healthy biology, and deliver potentially life-altering transformation for people and families affected by genetic disease. Spark is a member of the Roche Group.
- Website
- http://sparktx.com/
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