Senior Clinical Trial Manager / Clinical Trial Manager (Clinical) - Remote - REF10770Y
Company: ProPharma Group
Location: Saint Louis
Posted on: June 25, 2022
Job Description:
Company DescriptionProPharma Group is an industry leading,
single source provider for regulatory compliance,
pharmacovigilance, and medical information services across the full
development lifecycle for pharmaceutical, biotechnology, and
medical device companies. Operating around the world with offices
in Australia, Canada, Germany, Japan, the Netherlands, Sweden,
United Kingdom, and the United States, ProPharma Group's fully
integrated service offerings will provide clients with a
comprehensive suite of global support services that are required to
be competitive in today's dynamic markets. We build successful
long-term relationships with clients by providing leading industry
knowledge, experience, and proven processes.Job DescriptionA
Clinical Trial Manager is responsible for managing all aspects of
clinical trials to support the development, validation, and
commercialization of first -in - class assays interrogating
circulating tumor DNA (ctDNA) and cell free fetal DNA (cffDNA) for
the non -invasive detection and diagnosis of various cancers and
fetal chromosomal anomalies. The Clinical Trial Manager should have
experience in protocol implementation, site monitoring, and
recruitment site management. The candidate will work closely with
internal clinical trials, R&D and scientific communications
teams to accomplish this end.Primary Responsibilities
- Responsible for the implementation of clinical trial activities
per study protocol. Works closely with investigative site
personnel, CROs, and other study vendors
- Manage study contracting, budget and payment process for all
clinical trial vendors including investigational sites
- Design study related documents, including but not limited to
study protocol, informed consent forms, CRFs, and regulatory
binders
- Train CROs, vendors, investigators and study coordinators on
study protocol and relevant requirement
- Monitor and track clinical trial progress and provide status
update to stakeholders
- Partner with other research and development groups to achieve
deliverables
- Professionally handle access to HIPAA information
- This role works with PHI on a regular basis both in paper and
electronic form and have an access to various technologies to
access PHI (paper and electronic) in order to perform the job
- Employee must complete training relating to HIPAA/PHI privacy,
General Policies and Procedure Compliance training and security
training as soon as possible but not later than the first 30 days
of hire.
- Must maintain a current status on training requirements.
- Employee must pass post offer criminal background
check.Knowledge, Skills, And Abilities
- Familiar with the FDA regulations relevant to clinical
trials
- Experience in managing CROs is desired
- Proficiency in MS Word, Excel and PowerPoint Good organization
and planning skills
- Strong interpersonal skills and communication skills (both
written and oral) Strong leadership skills, self-motivated,
adaptable to a dynamic and fast paced environment
- Ability to collaborate with the study team, cross functional
team members and external collaborators
- Excellent interpersonal, communication, computer, and technical
skills
- Excellent oral and written communication skills
- Must be detail oriented.
- Flexible and very adaptable to change
- Must have excellent organizational and time management
skills.
- Ability to prioritize and handle multiple tasks and projects in
a fast-paced environment
- Comfortable with logistics and coordination activities
associated with providing support to C-suite executivesOncology
Experience RequiredQualifications
- Bachelor's degree in life sciences, or other relevant
discipline required, an advanced degree preferred
- Minimum of 8 years of related experience
- 2- -5 years of experience in managing clinical trials in a
regulated environmentAdditional InformationThis is a 6 month
contract role, with possible extension.We celebrate our differences
and strive to create a workplace where each person can be their
authentic self. We are committed to diversity, equity, and
inclusion. Employees are encouraged to unleash their innovative,
collaborative, and entrepreneurial spirits. With a holistic
approach as an Equal Opportunity Employer, we provide a safe space
where all employees feel empowered to succeed.We are an equal
opportunity employer. M/F/D/V***ProPharma Group does not accept
unsolicited resumes from recruiters/third parties. Please, no phone
calls or emails to anyone regarding this posting.***
Keywords: ProPharma Group, St. Louis , Senior Clinical Trial Manager / Clinical Trial Manager (Clinical) - Remote - REF10770Y, Healthcare , Saint Louis, Missouri
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