Clinical Study Leader

Company: Science 37
Location: Mentor
Posted on: September 13, 2020

Job Description:

Science 37 is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients' homes. Backed by venture investors such as Glynn Capital, Google Ventures, Redmile Group, dRx Capital and Lux Capital, we are revolutionizing the clinical trial industry, one patient, at a time. To help us achieve our goal, we are seeking a razor-sharp  Clinical Study Leader  eager to make an impact within a mission-driven organization.

The Clinical Study Leader is a member of the Clinical Operations department accountable for on-time and on-budget delivery of clinical study(ies) at the highest quality standards.

The Clinical Study Leader will have a broad therapeutic knowledge leading the multifunctional study management team within a matrix environment. The study management team is collectively responsible for planning, solutioning, recruiting, executing, and close-out of clinical studies, within the scope of the client agreement. In doing so, the Clinical Study Leader will oversee all operational aspects of clinical trials according to and in compliance with corporate and project Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonisation (ICH) guidelines and other applicable federal (FDA) and state regulations, in order to achieve established goals within timelines and budget.

The Clinical Study Leader is the single point of contact to client study teams working with internal and external stakeholders. This individual is accountable for the delivery of the project objectives on time and on budget and is responsible for end-to-end execution of clinical trials to ensure effective and timely internal and external communication of study progress, issues, and plans for resolution. The Clinical Study Leader is also responsible for efficient resourcing and financial management of studies under his/her supervision. In this capacity the Study Leader will have line management responsibilities ensuring that direct reports will have the appropriate supervision and mentorship needed to foster learning and provide career development, guidance and training to advance their skillsets.

Duties & Responsibilities Duties include but are not limited to:

Project Guidelines and Communication:

Develop study plan outlining planning, execution, and closeout milestones.

Develop a study management plan in conjunction with the Director of Clinical Operations, and sponsor representative(s) outlining target KPIs, risk assessment, and contingency planning.

Lead multi-disciplinary Study Management Team.

End-to-end management of clinical studies to ensure appropriate resourcing and timely and high-quality delivery by all functional areas. Ability to identify and organize resources and services needed to accomplish tasks, set objectives, plan for contingencies, and managing time effect.

Assist in screening, selection, and management vendors in accordance with contractual timelines, sponsor specifications, quality, budget, and GCP.

Develop and monitor study metrics to continuously assess study progress.

Act as the primary point of contact between Science 37 and sponsor project team.

In collaboration with the study management team, and Marketing, develop a robust recruitment and retention data-driven strategic plan including risk assessment and contingency planning, at the start of the study and monitored throughout its duration and to close-down.

Project Analysis and Management

Identify critical project success factors for tracking, analysis and reporting including impact and probability of project risks.

Monitor and track study status, timelines, and budget expenditures; identifies opportunities and recommend implementation plan for efficiency measures.

Accountable for overall study budget, ensuring that all invoices are paid, issues are addressed, and revenues are booked in timely manner.

Ensures timely data entry, query resolution and prompt resolution of data issues.

Coordinate assignment of needed resources for study conduct and completion with functional area leaders; ensure appropriate staffing to accomplish project goals within budget.

Identify out-of-scope work and reports the scope change process to leadership.

Responsible for review of study budget, expense reports and financial records (invoicing/units/expenses) in conjunction with appropriate project team members.

Manage clinical research coordinators and their activities on each study.

Ensure that study activities (personal and those of the Clinical Research Coordinators) are properly tracked and entered into the company’s time tracking/project management/resource planning software tool in a timely manner.

Ability to analyze data and information to derive conclusions and drive critical decision-making

Leadership

Accountable for development, oversight and delivery of team training for specific projects.

Applies expertise in day-to-day clinical operations activities, collaborate with internal and external cross-functional team members to develop study documents and manuals, including protocols, ICFs, manuals, presentation decks, risk plans, etc.

Determines needed project processes and trains study teams; maintains study team knowledge and application of project processes.

Establish and communicate team performance expectations and guidelines.

Mentor and assist in coaching/training Clinical Research Coordinators.

Conduct performance reviews, calibration sessions and feedback discussions for clinical research coordinators. Perform competency assessments across his/her team and implements and monitors development plans with direct reports.

Manage performance of external service providers as required.

Provide performance evaluation input for Science 37 project team members and service providers.

Participate in development and review of departmental Standard Operating Procedures (SOPs), guidelines, intradepartmental procedures, and other continuous process improvements programs, as assigned.

Business Development

Support the development of project proposals by participating as Subject Matter Expert (SME) in internal and external meetings. Represent Science 37 in sponsor and vendor relationships as required.

Understand customer needs and appropriately influence decision-making.

Qualifications

Bachelor’s degree required. Advanced degree or equivalent clinical research experience preferred.

8+ years of in-depth knowledge of pharmaceutical/biotech-sponsored clinical study management experience or equivalent applicable experience.

Medical and scientific knowledge preferred.

Skills and Competencies

Expertise in study management - Demonstrate ability to successfully manage people and multiple clinical studies. Proactive problem-solving abilities and follow-through.

Knowledge of field organizational strategies - Ability to adapt to a rapidly changing work environment, managing competing priorities. Successful decentralized team management and situational responsive decision-making.

Extensive knowledge of clinical research - Understands the drug development process, clinical research industry and the relevant environments in which it operates. Knowledgeable about the critical elements for success in clinical trials, with a history of participation in and contribution to these activities. Ability to review protocols and assess the risks of programs and projects.

Team management and collaborative capabilities - Demonstrated experience in building and guiding organizational teams. Commitment to collaboration, within and across departments. Leverages each team member’s unique background and perspective to achieve team goals while providing clear direction and accountabilities.

Interpersonal Savvy – Understands interpersonal and group dynamics and reacts in an effective and tactful manner. Confidently interacts with key internal and external stakeholders including department heads, senior management, PIs, vendors and consultants. Has a range of interpersonal skills, handles constructive criticism and learns from it, and approaches with the ability to select a best-fit approach. Has a good understanding of other company functions and their inter-relationship to achieve project deliverables.

Strong motivational and influence skills – Ability to motivate, influence and guide team members and direct reports; gains commitments from others.

Strong communication and presentation skills - Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive Sponsor, study team member and internal Science 37 relationships. Ability to conduct effective presentations.

Computer skills - Working knowledge of MS Office suite and Google applications. Able to generate business correspondence, create forms and generate reports as required. Willingness to gain expertise in the use of propriety software.

Financial Skills - Manages and tracks multiple study budgets with a good understanding of study financials.

Practices professionalism and integrity in all actions - Demonstrated commitment to teamwork, cooperation, self-control, and flexibility in all areas of work.

Leadership – Communicates and exhibits leadership behavior consistent with the company-wide keystone focus. Ability to have difficult/crucial conversations.

Capabilities

Up to 20% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed.

Ability to communicate in English (both verbal and written).

Supervision

The incumbent reports to the Director Clinical Operations/Associate Director, Clinical Operations or Senior Vice President of Clinical Operations, who will assign projects and provide general direction and guidance. Incumbent is expected to perform duties and responsibilities with minimal supervision.

Direct Reports

Clinical Research Coordinators

Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed. Enjoy healthy catered lunches, snacks and beverages, and top-notch equipment such as the latest Macbook Pro, 4k monitors, and adjustable standing desks.

Have you managed investigator-initiated clinical trials from start up to close?  *

Have you managed sponsor-initiated clinical trials from start up to close?  *

Have you had any direct reports? How many?  *

Have you worked for a CRO?  *

Have you managed study budgets?  *

Have you worked for pharmaceutical / biotech companies?  *

Do you now, or will you in the future, require sponsorship for employment visa status (e.g., H-1B visa status, etc.) to work legally for our Company in the United States?  *

What are your compensation expectations for this role?  *

Authorization  *

I hereby authorize Science 37 to process my resume and personal information for the purpose of potential employment.

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Keywords: Science 37, Mentor , Clinical Study Leader, Other , Mentor, Ohio