- Project Administration - Acts as a primary liaison between the Company and vendor(s) to ensure study launch, conduct, and closeout according to company and regulatory requirements; coordinates project organization, implementation, and management activities between all Company operations and vendors.
- Financial / Contract - Manages the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses; oversees and tracks site payment issues as required; alerts Finance approval / rejection of vendor invoices to contracts; oversees vendor activities and that contractual agreements are achieved; assists in the negotiation and contracting process with vendors (CROs, labs, printers, etc.); performs ongoing review of project financial status of studies.
- Project Specific - May sign off / approve site selection from site feasibility assessments; reviews protocol, Case Report Forms, and edits specifications for consistency within each document, cross-checking these documents against each other; reviews and approves project plans for the study in accordance with Standard Operating Procedures (SOPs); maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools. Understand and support global program goals including site identification and assessment, patient/subject recruitment, Key Opinion Leader (KOL) and Steering Committee development, and medical affairs support.
- Reporting - Produces and distributes status, resourcing, and tracking reports, and functional area plan to appropriate team members and management; alerts management to potential issues and ensures necessary corrective action is taken.
- Communication - Independently prepares and presents study material at vendor meetings and communicates outcomes to project team at review meetings; attends external and internal meetings as necessary and required.
- Vendor Management - Develops strong relationships with vendors to support project needs; supports Procurement and Clinical Operations by participating in Request for Proposal development; may participate in evaluating potential CROs (and/or other vendors), including participation in proposal defense meetings. Supervise CRO from study start-up through close-out.
- Knowledge / Training - Demonstrates mastery of current therapeutic environment and drug development trends; facilitates internal / external training requirements in accordance with protocol and/or project initiation, set-up, requirements, including therapeutic, protocol specific, and process training.
- Project Leadership - Manages a project as the Clinical Trial Manager; may manage multiple projects and/or programs; acts as a liaison and facilitator between other departments within the company to ensure project related tasks and/or issues are addressed.
- Management - May mentor other Clinical Operations project management team members and clinical staff; facilitates team building and communication.
- May represent company at professional meetings or seminars; performs other work-related duties as assigned.
- BA/BS in the life sciences, nursing, pharmacy, or equivalent, and 5+ years of clinical research experience in a biotechnology company, contract research organization (CRO), or pharmaceutical company, or equivalent combination of education and experience
- Experience in clinical vendor management
- Previous technical and managerial experience in conducting multi-national and/or local clinical trials in a hospital setting, biotechnology / pharmaceutical company, or CRO; at least two years must have been spent actively managing the full scope of clinical research projects (i.e., accountability across all functional areas including budget ownership)
- Thorough knowledge of regulatory requirements, drug development, and clinical monitoring procedures; Demonstrated proficiency with ICH/GCP guidelines
- Keen insight, independent judgment, and tactful discretion; strong ability to manage time and work independently; strong organizational, presentation, documentation, and interpersonal skills as well as a team-oriented approach; advanced proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), web-based systems, email, and voicemail skills; experience with timeline management systems / programs (MS Project, Smartsheet, etc.)
- Flexibility and the ability to mentor new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment; ability to assist in and / or champion establishing and maintaining standards, system integrity, and ensuring quality assurance measurements
- Experience or exposure to infectious disease clinical trial(s)
- Experience or exposure to first-in-human clinical trial(s)
- Experience or exposure to gene or cell therapy clinical trial(s)
- Experience in early phase trials (Phase I - II)
- Experience as a traveling Clinical Research Associate / Clinical Site Monitor
- Minimal travel may be required (up to 25%)
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Clinical Trial Manager - Durham, United States - Precision BioSciences Inc
Description
SummaryThe Clinical Trial Manager (CTM) is responsible for the management of clinical trial(s) from vendor selection through Clinical Study Report (CSR) completion. The CTM is accountable for successful delivery of assigned clinical team activities at the project level by meeting company and regulatory requirements according to time, quality, scope, and budget constraints.
**Please note, Precision BioSciences mandates COVID-19 vaccination of all employees. Accommodations may be made in accordance with applicable law.
Essential Duties and Responsibilities
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
Required:
•This role will be able to function remotely in accordance with company guidelines but is subject to change as needed.
Precision BioSciences, Inc. (Nasdaq: DTIL), is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS genome editing platform. This isn't just a statement supporting the products that we're developing - it's a statement that speaks to our collective desire to do our part in improving the lives of those around us. ARCUS is a highly specific and versatile genome editing platform designed with therapeutic safety, delivery, and control in mind. Using ARCUS, Precision is developing in vivo gene correction therapies for genetic diseases. Our team includes pioneers in genome editing, leaders in business, and a full staff of talented and committed people who are excited to be a part of medical and scientific breakthroughs. For additional information, please visit www.
Precision BioSciences actively fosters an inclusive environment to ensure we attract and retain the best talent; we value diversity of life experiences and perspectives; and we encourage innovation in pursuit of our mission. We provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
