Clinical Project Manager

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Overview:
The Project Manager is responsible for the management and coordination of conduct of assigned clinical research trials sponsored by the pharmaceutical industry. These activities include effective planning, execution, reporting and evaluation of clinical trials. The Project Manager provides direction, but not supervision, to the clinical trial project team, including both Clinical Trial Assistants (CTA) and Clinical Research Assistants (CRA). The Project Manager serves as the primary contact with the sponsor for project-related activities and as liaison with CRAs, CTAs, clinical research sites, vendors and other internal departments. The Project Manager ensures assigned projects proceed according to the project scope of work, protocol and other planning documents, which outline designated timelines and within the approved budget.

Primary responsibilities:
• Overall coordination and management of clinical trials from contracting to closeout.
• Execution of technical, protocol-specific and operational aspects of assigned trials.
• Collaborate with all stakeholders ensuring effective resolution of study issues as they arise to effectively meet timelines, deliverables and budget constraints.
• Ensure trails meet sponsor requirements, as well as adhered to Catawba Research’s standard operating procedures (SOP) and work instructions.
Clinical trials management
• Will oversee multiple clinical trials simultaneously.
• Ensures assigned trials are “audit ready” at all times.
• Assist in the review and approval of clinical protocols, Informed Consent Forms (ICF) and Case Report Forms (CRF).
• Create study-specific planning documents to manage trial safety, data, monitoring and timelines.
• Coordinates effective execution of work to conduct trials with CRAs and CTAs, as well as sponsors and vendors.
• Ensures study team, both internal and site-based, is compliant with SOPs, protocol and other documents as required.
• Provides consistent updates to staff, sponsor, vendors and other stakeholders regarding status and progress of trial.
• Responsible for writing/approving clinical project deliverables, such as scope definition documents, source documents, monitoring tools and training materials.
• Establish and oversee IRB submission and approval process.
• Review and approve monitoring visit reports.
• Collaborate with sponsor and vendors to manage investigational product and clinical trial supplies, including shipment and retention.
• Responsible for providing study-specific training and documentation of training.
• Responsible for developing presentations and other materials for investigator meetings.
• Provide timely processing and completion of safety concerns and/or serious adverse events (SAE) occurring within trials.
• Perform site monitoring, as needed.
• Timely resolution of data queries.
• Review and approve clinical study reports.

Qualifications:
• At a minimum, a Bachelor’s Degree in the field of biomedical science (i.e., biology, chemistry, microbiology, health/life sciences, biomedical engineering, pharmacology, etc.) or equivalent experience within a clinical research organization.
• At least 2 years’ experience overseeing clinical trials from study start-up to closeout
• Knowledge and proficient use of CTMS, EDC, project management software and other technology-based programs (including Microsoft Office programs).
• Excellent oral and written communication skills.
• Excellent time management and organizational skills.
• Mindset of superior customer service for sponsors and sites.

To apply:
Send in a single document containing both your cover letter and resume via email to shannon@catawbaresearch.com. The cover letter should specifically state why we should hire you based upon your specific skill sets and desired work environment. We prefer a cover letter telling us who you are outside of what we can see in your resume. We want to ensure you are the perfect fit, not just for the work we conduct, but the culture we strive to maintain.

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