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Site Director, Clinical Operations

2 months ago

Orlando, United States Flourish Research Full time

Highland Performance Solutions is proud to be leading a retained search for Flourish Research for a Site Director to lead the Orlando, FL (Winter Park) location.


Who We Are

Advancing the health and wellness of society through clinical trials, Flourish Research is one of the largest integrated clinical research site companies in the US, with best-in-class sites who have a strong brand and track-record of recruiting and retaining a highly diversified patient populations in the therapeutic areas of cardiology, metabolic disorders/renal, CNS, pulmonology, and vaccines. Flourish’s fully integrated site network strategy with centralized infrastructure and investment in technology allows for superior patient access, engagement, and diversification as well as consistent, high quality data delivery. Flourish has differentiated its sites through an investment in Quality Management Systems, a focus on patient diversity, and deep clinical expertise backed by SMEs in its Centers of Excellence focus areas.


The Role & Opportunity

The Site Director in Orlando, FL (Winter Park) will be responsible for the execution and oversight of the clinic’s operational functions, inclusive of P&L, and will execute on Flourish Research’s mission of providing high-quality clinical trials to our growing client base utilizing a fiscally responsible, collaborative approach. As part of the local leadership team, you will report directly to Regional Director of Operations.


Responsibilities

Financial & Operational:

  • Commitment to the Flourish Approach and implementation/oversight of corresponding clinical and operational initiatives.
  • Responsible for site level operational and financial metrics including budget targets, reports, and actions for continuous improvement activities.
  • Must become knowledgeable about the history, operations, positioning and other facets of the site and Flourish Research that has led to its current market position.
  • Regularly analyzes operational volume and labor staffing models to determine optimal staffing requirements.
  • Leads, develops, mentors, and engages a team of clinic and administrative staff to execute against the clinical/operational strategy.
  • Responsible for driving performance and coaching/development objectives.
  • Own the P&L for their individual site, responsible for executing against margin/EBITDA targets and other performance related metrics.
  • Implement plans & processes to maintain productivity and profitability.
  • Effectively uses financial levers to manage a P&L and operational budget, inclusive of fixed and variable costs and requesting capital expenditures.
  • Understand a clinical trial agreement budget and how it applies to their operations to maximize revenue opportunities.
  • Responsible for reviewing, understanding and driving key performance indicators.


Team Management:

  • Recruit, train, assess, develop and retain clinical and administrative staff to ensure successful team and business performance.
  • Use routines and best practices to assess performance, provide recognition and performance coaching when gaps are identified.
  • Identify site level management development and training needs and ensure training is obtained.
  • Serve as the change, culture and engagement champion, driving People and Culture initiatives for the site in partnership with site level and regional management.
  • Work with the training team to develop training programs for their clinical and administrative staff.
  • Direct specialty recruiting strategy to fulfill needs for short, mid and long-term site level success and market development.
  • Collaborate with other Flourish site directors to problem-solve and leverage best practices across the region.


Site Management:

  • Work closely with the Quality and Risk teams and department managers to implement Standard Operating Procedures (SOPs) and policies to ensure compliance with Good Clinical Practices, federal regulations/ICH guidelines, HIPAA laws and sponsor protocols.
  • Attend pre-study qualification visits. Participate in ongoing and close-out monitoring visits with sponsor/(CRO) representatives.
  • Ensure the safety of study participants through appropriate training of staff and adherence to regulatory guidelines.
  • Ensure continuous high-level involvement by principal investigators as required by FDA regulations/ICH guidelines and SOPs by maintaining frequent communications with and coordinating the training of physician investigators and their staff.
  • Ensure data integrity by working closely with Quality Control (QC) for the timely submission of quality data to our sponsors.
  • Holds the Flourish shared services functions accountable to deliver against agreed upon service level targets; including but not limited to Human Resources, Feasibility, Business Development, Budgets and Contracts, Quality, Training, Information Technology, Realtime and Finance.
  • Establish and manage effective patient acquisition programs to ensure successful enrollment of clinical trials at their site; including, management of referring physician practices.


Minimum Qualifications

  • Bachelor's degree in basic science, nursing or healthcare management
  • Minimum of 5 years’ experience in clinical research
  • Minimum 5 years’ experience in an operational leadership role while managing site level leaders
  • Minimum 8 years of experience in a clinical research role
  • Strong multi-tasking and problem-solving skills
  • Entrepreneurial spirit with independent working style
  • Strong planning and execution skills to operationalize strategic imperatives
  • Strong leadership and team building attributes
  • Travel may be required for this role; will vary depending on business need and client requirements
  • Occasional night and weekend work schedules may be required
  • Conversational proficiency in Spanish is not required but is ideal.


Professional Skills

  • Ability to forecast and execute business planning, both from an operational and financial aspect.
  • Ability to effectively multitask and prioritize competing demands in a fast-paced, dynamic environment.
  • Capability to work independently, adept at on-the-spot problem-solving in a business context.
  • Proficiency in forecasting and executing business planning, encompassing both operational and financial aspects.
  • Demonstrated aptitude in tactical and strategic planning for site management, coupled with strong leadership qualities.
  • Willingness to travel as required by the role, with the extent varying based on business needs and client requirements.
  • Excellent collaboration skills to foster effective teamwork and partnerships.
  • Exceptional oral and written communication skills for clear and concise interaction.
  • Proficient in Office365 products and other relevant computer applications.
  • Experience in reviewing and implementing Standard Operating Procedures (SOPs).
  • Strong problem-solving skills with a focus on risk assessment and impact analysis.
  • Proven track record in process improvement initiatives.
  • Proficient in negotiation and conflict management techniques.


Compensation Package

  • $110k - $130K plus 20% Bonus Potential
  • Annual Performance-Based Merit Salary program
  • Paid Time Off
  • 8 Paid holidays, Including 2 Floating Holidays
  • 401K plan: 4% Match
  • Employee Review and Performance Program
  • Tuition Reimbursement Policy
  • Employee Referral Bonus
  • Supplemental Parental Leave


Requirements for Application

  • Apply via LinkedIn or send a resume and salary requirements to: executivesearch@highlandperformancesolutions.com
  • No faxes or phone calls will be accepted
  • Flourish is an equal opportunity employer