Executive Director, CRO Services

Summary: Responsible for the strategy, development, and operations of the CRO Services division at ProSciento. Primary duties will include outlining and executing the goals and strategies supporting growth and continued development of CRO Services in support of multi-center trials. CRO Services Leadership will oversee Project Management and CRO Clinical Operations as well as regularly interacting with leadership, clients and investigational sites. Performs duties in accordance with company’s values, policies and procedures.

Essential Duties and Responsibilities include the following. Other duties may be assigned at the company’s sole discretion.

• Develops goals and strategies for multi-site growth as well as evaluates progress.
• Ensures operational and financial performance of Project Management and CRO Clinical Services.
• Problem solves operational and financial challenges in accordance with contractual obligations.
• Develops, monitors, and responds to project and departmental performance metrics.
• Monitors operational performance and client satisfaction via weekly and monthly reporting.
• Oversees hiring and resource management of Project Management and CRO Clinical Services.
• Assists in the creation, development, and execution of Standard Operating Procedures (SOPs), Work Instructions (WIs), and corporate guidelines.
• Assists in development and tracking of quarterly goals for each group/functional area.
• Supports subject recruitment strategies.
• Creates and supports strategic and tactical plans for growth of the site database.
• Assesses needs for third party vendor requirements and contributes to selection/qualification and performance/oversight of deliverables.
• Ensures utilization and compliance of ProSciento systems of record (eTMF, CTMS, etc.).
• Contributes to the bidding process.
• Supports Business Development by serving as a functional expert.
• Attends and contributes to project launch activities (post-award activities).
• Offers suggestions for improvement and monitors outcome of such if deficiencies are identified.
• Meets with ProSciento leadership regularly and as needed to assess, manage, and create new processes.
• May serve on the Senior Management Team.
• Represents the company vision.
• Meets with COO weekly.
• Communicates to all stakeholders’ performance standards and expectations.
• Practices and adheres to the mission statement and ProSciento values.
• Completes any training assignments by the due date.
• Ability to travel independently to collaborate with external sites.
• Self-identifies key areas for process improvement.
• Manages profit and loss (P&L) centers within budget.
• Executes initiatives of executive management with minimal oversight.
• Works independently to identify and implement process improvement.
• Manages P&L and non-P&L centers within budget.
• Contributes to executive management planning on an ad hoc basis.
• Contributes to strategic planning on an ad hoc basis.
  
  
  

Supervisory Responsibilities:

Directly hires and supervises director level personnel in Project Management and CRO Clinical Services. May play a mentorship role for manager and director level individuals in cross-departmental development opportunities.

Competencies:

• Building Effective Teams: Blends people into teams when needed; creates strong morale and spirit in his/her team; shares wins and successes; fosters open dialogue; lets people finish and be responsible for their work; defines success in terms of the whole team; creates a feeling of belonging in the team.
• Organizational Agility: Knowledgeable about how organizations work; knows how to get things done both through formal channels and the informal network; understands the origin and reasoning behind key policies, practices, and procedures; understand the cultures of organizations.
• Process Management: Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can’t; can simplify complex processes; gets more out of fewer resources.
• Motivating Others: Creates a climate in which people want to do their best; can motivate many kinds of direct reports and team or project members; can assess each person’s hot button and use it to get the best out of him/her; pushes tasks and decisions down; empowers others; invites input from each person and shares ownership and visibility; makes each individual feel his/her work is important; is someone people like working with.
• Business Acumen: Knows how businesses work; knowledgeable in current and possible future policies, practices, trends, technology, and information affecting his/her business and organization; knows the competition; is aware of how strategies and tactics work in the marketplace.
• Creativity: Comes up with a lot of new and unique ideas; easily makes connections among previously unrelated notions; tends to be seen as original and value-added in brainstorming sessions.
  
  
  

Qualifications:

To perform this job successfully, an 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 and Experience:

Master’s level degree or PhD in related field is preferred; clinical science and/or regulatory background in metabolic diseases (or other therapeutic areas within ProSciento’s portfolio) is required. Minimum of 10 years industry experience, including CRO industry experience with a strong working knowledge of Project Management and Clinical Operations. Global experience is required.

Skills, Knowledge, and Abilities:

Proficient at development and management of P&L at the department and project levels. Experienced at organizational modeling to optimize operational and financial performance. Experienced at managing client portfolios (delivery and business development).

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.

Math Ability:

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

Reasoning Ability:

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Computer Skills:

To perform this job successfully, an individual should have knowledge of Microsoft Office 365 software.