Sr. Clinical Project Manager
- Employer
- Spark Therapeutics
- Location
- MA, Massachusetts
- Salary
- Salary not provided
- Closing date
- Feb 10, 2022
View more
- Discipline
- Life Sciences, Biotechnology
- Job Type
- Project Manager
- Organization Type
- Biotech
Job Details
- Identify study level risks
- Develop, maintain and implement risk mitigation and contingency plans
- Ensure key functional lines and senior management are informed of study level major risks and contingency/mitigation plans
- Monitor progress against study plan and develop and implement operations risk management plans across the project
- Determine study requirements, define specifications/scope of work, and initiate and lead the selection of vendors
- Manage financial aspects for clinical vendors
- Manage and oversee CRO and clinical vendor relationship and activities; implement plans for efficient and effective vendor oversight
- study timeline and budget
- risk management plans
- investigator/site/country/patient recruitment plans
- request for proposal [RFP] process for clinical vendors
- vendor specifications, management plan and oversight
- communication plans (including site and sponsor communication, vendor communication as well as site escalation)
- ongoing data review plans
- educational/training plans
- performance and compliance metrics
- clinical protocols and amendments
- informed consent templates
- site feasibility questionnaires
- case report forms [CRFs] and CRF guidelines
- trial master file plan
- data / integrated voice recognition system [IVRS] management plans
- pharmacy brochures, and regulatory binders
- data monitoring committee charters
- clinical study reports
- 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 team
- 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.
- 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
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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.
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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