Clinical Trial Manager

• Collaborate/coordinate Executive Leadership Team to strategically get approval for and plan clinical trials from start –
  up through close-out in accordance with all pertinent regulations.
• Oversee daily activities and operations of a study to include planning, implementation, tracking and administration.
• Identify and recommend trial sites, to include visiting site as required
• Arrange and oversee all visits.
• Develop development and approval of study documentation, define and drive study timelines and milestones.
• Resolve issues in a proactive and timely manner and escalate unresolved issues.
• Lead a cross functional team as necessary for clinical trials and update in a timely manner.
• Manage the budget process of clinical trials, reporting to Executive Team as applicable.
• Review and provide feasibility documentation.
• Work closely with Compliance Director on claims substantiation and regulatory documentation as applicable.
• Support regulatory processes, as required.
• Primary technical lead for strategic clinical needs.
• Responsible for providing regular project updates and changes in priorities to V.P.
• Meet regularly with Sr. R&D Product Innovation Manager to establish strategic project initiatives and lab movements,
  as required.
• Coordinate with R&D Lab Manager all in-house work and data required for clinical trials.
• Coordinate and author work on manuscripts and patents as necessary from start to submission and approval.
• Serve as review for manuscripts written by R&D staff.
• Work on ideas regarding new products as applicable.
• Represent company with clients, strategic partners and at trade shows as applicable.
• Ability to influence hiring/terminating/disciplining in coordination with direct supervisor and HR Manager.
• Write articles and prepare presentations etc.
• Maintain appropriate files.
• Other duties as required.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or
responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at
any time with or without notice.

Education/Certification: Advanced Degree in a related field of science
Work Experience: 5 + years of relevant experience

An employee in this position should have the following education/certifications, work experience,
and skill set:

• Skill set and competencies:
• Computer use with applicable programs
• Project and time Management
• Budget experience
• Pay attention to details
• Display professionalism and integrity
• Adapt to company changes
• Advanced laboratory skills and understanding of the R&D process
• Accomplish tasks in timely manner and seek solutions as required
• Listen, speak, communicate effectively; cooperate with others; consider feelings and viewpoints
  of others; analyze viewpoints objectively
• Technical writing: (literature, presentations, posters)
• Work in team or individually
• Knowledge of enzyme functions and applications
• Punctuality

WORK ENVIRONMENT: Works in inside environment. May be exposed to dust in warehouse.

PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an
employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to
enable individuals with disabilities to perform the essential functions of the job. While performing the duties of
this job, the employee is required to:

• Frequent: Prolonged periods sitting at a desk
• Occasional periods of standing in lab
• Extensive work on computer (visual and typing)
• Use fingers for – picking, pinching and typing
• Use of telephone
• Engage in repetitive motion of the wrists, hands and/or fingers
• See with close visual acuity to perform an activity such as prepare and analyze data,
  transcribe, view a computer terminal or equipment monitor, or read
• Occasional: Walking
• Ascend and descend stairs

TRAVEL: Travel required.

USUAL HOURS OF WORK: Monday – Friday: 8:00 a.m. – 4:30 p.m.
Satisfactory attendance is essential to this position.