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
Project Guidelines and Communication:
Develop study plan outlining planning, execution, and closeout
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
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
Project Analysis and Management
Identify critical project success factors for tracking, analysis
and reporting including impact and probability of project
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
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
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
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
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
Establish and communicate team performance expectations and
Mentor and assist in coaching/training Clinical Research
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
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
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
Understand customer needs and appropriately influence
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
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
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
Up to 20% travel, as needed, for project team meetings, client
presentations and other professional meetings/conferences as
Ability to communicate in English (both verbal and written).
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.
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?
I hereby authorize Science 37 to process my resume and personal
information for the purpose of potential employment.
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