Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Join us as Principal Operations Strategy Specialist - To provide expert guidance in the formulation and execution of clinical trial strategies, optimize trial processes, collaborate with key stakeholders to ensure strategic alignment, and drive initiatives that enhance the overall success and efficiency of our clinical trials.

What You'll Do:
• Collaborate with internal constituents to identify and recommend plans for assigned area that align with commercial win strategy; contributes to the proposal deliverable and key operations messages.
• Develop plans that enable problem solving, yields solutions and contribute to the triage process within clinical operations that meet proposal deliverables.
• Work collaboratively with leading functional roles to develop a budget that reflect operational strategy and work with operational leadership team to
achieve profitability targets, as well as various internal stakeholders to enhance proposal regarding efficiency management to decrease costs.
• Support and ensure delivery of the development of the operations segment of the proposal deliverable within prescribed timelines, disseminates operational
strategy to proposal team and develop KPIs, ensuring a successful operation segment of the deliverable.
• Collaborate with the cross functional team in matrix environment to establish an efficient and aligned process within clinical operations.
• Support operations escalation process and may advise commercial strategy team.
• Contribute to cross functional satisfaction and proposes recommendations on future plans and actions to ensure the overall success of the process and outcomes.
• Work with leading functional roles to propose and implement revisions for post award to successfully execute proposal.
• Provide input/develops plan and recommendations to effectively leverage opportunities to achieve targets while enhancing customer relations.

Education and Experience:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years') or equivalent combination of education, training, & experience.

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills and Abilities:
• Thorough understanding of clinical project management, the business organization and functional areas
• Demonstrates solid customer relationship management skills and commercial acumen
• Ability to work in a high pressure/time sensitive environment
• Ability to multitask, with attention to detail
• Strong proposal development knowledge and skills
• Demonstrated project management and planning skills
• Strong organizational agility and demonstrates a drive for results
• Demonstrates influence and negotiation skills
• Ability to build effective and collaborative peer and cross functional relationships, works effectively in teams and demonstrates global and cultural awareness
• Analytical skills, excellence in oral and written communications, strong attention to detail, prioritization and time management proficiencies
• Thorough understanding of sponsor/CRO business practices and solid knowledge of operational/financial practices, SOPs, GCPs, and FDA/ICH guidelines

Working Conditions and Environment:
• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.

Physical Requirements:
• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Frequent mobility required.
• Occasional crouching, stooping, bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.