Responsible for the operational strategy, timeline development, and initial study deliverables for ProSciento CRO projects. Takes a lead role in developing operational solutions for CRO proposals and awarded projects. Supports studies from time of RFP through study launch, ensuring effective handoff of newly awarded projects to the CRO operational team. Conducts lessons-learned assessments following key project milestones.  Creates a high-performance culture through leadership, coaching and development to achieve delivery of project services.  Assesses the effectiveness of systems and processes for CRO projects through measurement of performance against defined time, quality and cost targets.  Leads and supports corporate projects that expand and improve CRO services.  Fosters a culture that drives customer-focused solutions, personal accountability, and delivery excellence. Performs duties in accordance with the company’s values, policies and procedures.

DUTIES AND RESPONSIBILITIES:

• Represents CRO operations in the pre-award process by developing and or reviewing sections of proposals related to operational strategies and presenting to potential clients at bid defense and other BD-related client meetings.
• Supports business development activities, contributes to proposal development, creates project level operational strategy, represents operational capabilities at client and sales meetings, and participates in BD and relationship management activities at conferences.
• Ensures the timely and customer-focused execution of initial project deliverables with a focus on quality.
• Ensures project risks and potential contingencies impacting time/quality/cost of deliverables are discussed with ProSciento senior management through appropriate escalation pathways.
• Ensures initial project targets are met with client satisfaction, and that services are provided with the highest quality standards through compliance with documented policies and procedures.
• Participates in site feasibility activities as needed and supports strategic site partnership relationships.
• Fosters team building, positive communication, and positive corporate culture.
• Leads business process expansion and improvement initiatives, contributing to continuing development of the CRO business unit.
• Assists in creating and revising Standard Operating Procedures (SOPs) and related documents.
• Designs, implements, and oversees business initiatives as defined by Supervisor and Executive Management.
• Acts as mentor to members of CRO Services staff and other internal team members as appropriate.
• Improves the performance, productivity, efficiency, and profitability of departmental and organizational operations through the provision of effective methods and strategies.
• Provides subject matter expertise, advice, and project management support on selected aspects of clinical trial development and execution.
• Problem solves clinical situations along with key stakeholders and department heads as required. Provides recommendations for solutions.
• Creates and supports strategic and tactical plans for company growth.
• Attends project/implementation meetings as required (i.e., bid defense, BD handoff, and KOM).
• Practices and adheres to the ProSciento mission statement and values.

JOB REQUIREMENTS / QUALIFICATIONS/EDUCATION:

Qualifications:

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience:

Has an in-depth understanding of clinical trials operations from both the sponsor/CRO and clinical site perspectives.   A minimum of seven years of clinical research operations experience working in a CRO or equivalent organization. Experience working in the metabolic therapeutic space is preferred. Bachelor’s degree in biological science or another related field preferred and/or a combination of education and experience. Has a thorough knowledge and understanding of GCPs, applicable FDA rules, regulations, guidance documents, governing conduct of human clinical trials.

KNOWLEDGE, SKILLS, AND COMPETENCIES REQUIRED

Skills, Knowledge, and Abilities: 

Knowledge of clinical research process. General knowledge of research, regulatory, and quality assurance guidelines. Demonstrated ability to lead by influence, coach and mentor. Public presentation skills. Able to communicate via email, text, and Microsoft Outlook/Skype for Business meeting platforms. Interpersonal, communication, and organizational skills. Critical thinking and problem resolution abilities. Independent work ethic.

Language Ability:

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Reasoning Ability: 

Ability to solve practical problems and deal with a variety of abstract and concrete variables in situations where only limited standardization exists. Ability to establish facts, draw valid conclusions, and predict outcomes based on available (possibly incomplete) data. Ability to interpret a variety of instructions furnished in written, oral, diagram, mathematical, or schedule form.

Computer Skills: 

To perform this job successfully, individual should have knowledge of Microsoft Office 365 software, including Microsoft Project and Visio.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually moderate.

Travel may be required, up to ~10-15%.

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.

The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. While performing the duties of this job, the employee is regularly required to sit, use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk.

CONDITIONS OF EMPLOYMENT

WORKING CONDITIONS AND PHYSICAL EFFORT

The above job description does not imply these outlined duties are the only duties performed by this employee. The incumbent is expected to perform other related duties necessary for the effective operation of the department and company.

ProSciento reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and company.