Biometrics Project Manager

INC Research; Raleigh (NC); On-site; USD 80,000 - 100,000; Full time

Job summary

INC Research is seeking a Project Manager to oversee clinical studies ensuring compliance with contracts and quality standards. This role involves acting as the primary liaison among Customers and the project team, managing multiple projects, and maintaining high standards throughout the project lifecycle.

The ideal candidate will have a BA/BS in life sciences along with managerial experience in clinical research. Proficiency in project management tools and excellent interpersonal skills are essential. The role may require up to 50% travel.

Qualifications

• Project management experience in a contract research organization, pharmaceutical, or biotechnology company.
• Experience managing clinical research projects across functional areas.
• Thorough knowledge of FDA regulations, drug development, and project management procedures.

Responsibilities

• Acts as primary liaison to ensure study launch, conduct, and closeout.
• Manages multiple projects with minimal supervisor interaction.
• Maintains effective communication with the Customer and project team.

Skills

Project management

Interpersonal skills

Knowledge of FDA regulations

Proficient computer skills

Education

BA/BS in life sciences or equivalent

Tools

Word

Excel

PowerPoint

MS Project

Job description

INC Research is a full-service clinical research organization, providing the full range of Phase I to IV clinical development services for the world’s pharmaceutical, biotech and medical device industries. We do this across six continents, and we’ll do it for you too.

Job Description

Ensures the contracted services and expectations of a clinical study are carried out by the Company project team in accordance with the executed contract and the Customer’s expectations. Works in the role of a project manager on assigned project(s), which may range from single service studies to large full scope biometrics projects. Duties include primary liaison with Customers, Vendors, Senior Management, and/or Investigative Sites.

Essential Functions:

• Acts as a primary liaison between the Company and the Customer to ensure study launch, conduct, and closeout according to the Customer’s and Company’s contractual agreement. Ensures the study is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations.
• Serves as the team leader by overseeing the biometrics project team. Facilitates team building and communication. Acts as a liaison and facilitator between other departments within the Company for project related tasks and/or issues. Plans and projects resources required across all areas for studies.
• Manages multiple projects ranging in size and complexity from single service studies to large full scope biometrics projects, global projects and/or programs, with minimal interaction from supervisor. This includes management of resources, tasks, risk, and quality.
• Manages the executed contract and financial aspects of assigned projects/programs as needed. Ensures customers are invoiced in a timely manner and follows up on receipt of payment as needed.
• Maintains effective communication with the Customer and project team through oral and written correspondence, project status reports, and monthly progress reports, and ensures adequate documentation of each communication.
• Independently prepares information for internal review meetings.
• Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools. Produces and distributes status, resourcing, and tracking reports as well as functional area plan, to appropriate team members and senior management.
• Networks to acquire new and/or repeat business.
• Supports the Business Development Department by providing information on the Company Biometrics capabilities. Presents Company capabilities as well as project management specific responsibilities at Customer proposal defense meetings
• Works with Business Development and the Proposal/Contracts groups to develop proposals for Customer requested opportunities as needed. Works with this team to develop budgets and scope of work for the final contract as needed.

Other Responsibilities:

• Represents the Company at professional meetings or seminars.
• May develop and refine project management processes within the Company.
• Performs other work-related duties as assigned.
• May develop and/or review SOPs and WIs related to any area concerning biometrics project management.
• May develop and refine processes within the Company which lead to greater efficiencies or competitive advantages over other companies.
• Minimal travel may be required (up to 50%).

Qualifications

Requirements:

BA/BS in life sciences, communications, nursing, or equivalent related education and experience. Project management experience in a contract research organization, pharmaceutical, or biotechnology company. Experience actively managing clinical research projects across biometrics functional areas. Previous CRO experience and specific biometrics management experience. Other relevant experience preferred. Thorough knowledge of FDA regulations, drug development, and project management procedures. Demonstrated proficiency with ICH/GCP guidelines. Strong presentation, documentation, and interpersonal skills as well as a team-oriented approach. Proficient computer skills in Word, Excel, PowerPoint, MS Project, email and internet. Flexibility and ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment.

Disclaimer:

Tasks,duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.

Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.

Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.