Project Manager, Clinical Operations

The Project Manager, Clinical Operations is responsible for the management of clinical trial(s) from vendor selection through Clinical Study Report (CSR) completion. The Project Manager, Clinical Operationsis 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.

**This is an office based position in Durham, NC**

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.

• 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 of 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.
  • 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.
• 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.

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.

Required:

• BA/BS in the life sciences, nursing degree, or equivalent combination of education and experience
• At least 2 years of clinical research experience in a biotechnology company, contract research organization (CRO), or pharmaceutical company
• 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 2 years experience actively managing the full scope of clinical research projects (i.e. accountability across all functional areas and 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, Mavenlink, 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

Preferred:

• Therapeutic experience in clinical stage Oncology trials (ph I III)
• Experience in early phase trials (ph I II)
• Experience as a traveling Clinical Research Associate / Clinical Site Monitor

Travel Requirements

• Minimal travel may be required (up to 25%).

Location

This position is located at the main headquarters located in Durham, NC and is required to physically be and work in the office, in order to be most effective, and at managers discretion.

Precision BioSciences is dedicated to improving life through its proprietary genome editing platform, ARCUS. Precision BioSciences leverages ARCUS in the development of its product candidates which are designed to treat human diseases and create healthy and sustainable food and agriculture solutions. Precision BioSciences is actively developing product candidates in three innovative areas: allogeneic CAR T immunotherapy, in vivo gene correction, and food.

Precision BioSciences provides 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.