Operations Manager with Sundance Clinical Research
Company: Collaborative Strategies
Location: Saint Louis
Posted on: May 26, 2023
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Job Description:
OPERATIONS MANAGERCollaborative Strategies, Inc. is excited to
be conducting a search on behalf of Sundance Clinical Research.
This organization was founded in 2005 to serve the community of St.
Louis and help advance drug development. Sundance works to bring
awareness to the importance of participating in clinical research
studies. Their state-of-the-art, dedicated, multi-specialty
research facility works to test new treatments during the
multi-phase research and development process. These medical
treatments are not generally available and are provided to patients
at no cost. If you are looking for an organization where you can
really make a difference in the world of health care and have a big
impact on the organization, then this is the place for you! The
dedicated team at Sundance all works together to get the job done
and no job is too small for anyone - even the president! But the
leader of this company needs help managing the day-to-day
operations, which is why they are looking for an Operations Manager
to join their team.The Operations Manager will manage all aspects
of the operations and clinical research program of the site,
ensuring compliance, reporting on studies and maintaining the
site.This newly created position reports to the President and
responsibilities include the following:LEAD OPERATIONS OF CLINICAL
STUDIES: Responsible for the overall administration and
coordination of activities for clinical research studies and
programs. Promptly complete and submit feasibility questionnaires.
Meticulously oversee how the research plan is executed.
Troubleshoot and resolve any issues that arise during the course of
a study. OVERSEE CLINICAL RESEARCH STUDY PROTOCOLS: Implement
protocol standards developed by the pharma company and approved by
the Food & Drug Administration (FDA) and provide feedback.
Determine, implement and document enrollment procedures, data
management, essential documents management, trial monitoring and
operational project management. Supervise the lab coordinator
shipping clinical specimens in a secure manner as required by the
protocol. Oversee the regulatory coordinator''s file maintenance
for every study and tracking of participation in training conducted
by the pharma company. Perform quality reviews to ensure adequate
execution of protocols and site training, as needed. MANAGE
RECRUITMENT OF STUDY PARTICIPANTS: Develop a recruitment plan for
each study to include sponsor-provided advertising funds, methods
of recruitment, rate of recruitment and development of recruitment
scripts, etc. Ensure study participant enrollment and recruitment
goals are met or exceeded. Evaluate site''s website and Facebook
page on a regular basis for updates, post new study information and
link to the site''s CTMS system to enable interested subject
contact. DATA MANAGEMENT AND REPORTING: Generate reports on patient
enrollment and tracking on a regular basis and as needed, and
implement actions to correct inadequacies in reaching the site''s
enrollment goals. Ensure accurate, confidential and complete
compilation of data through oversight of the Quality Assurance (QA)
function. Conduct data analysis and reporting. Ensure maintenance
of source documents and subject files in accordance with policies
and procedures. MANAGE THE SITE: Conduct site meetings and
communicate information to keep staff informed. Maintain and manage
the inventory of needed equipment, supplies and outsourced services
with acceptable suppliers in a cost-effective manner. Ensure the
site is maintained in an attractive, safe and efficient manner.
Perform human resources duties including ensuring compliance with
human resources policies, posting positions on Indeed or other
recruitment tool, screening and scheduling applicants, assisting
with offers to applicants, onboarding of new staff, monitoring
overtime and paid time off and acting as a liaison between staff
and payroll. Draft new policies for the employee handbook as needed
and review collaborate with the President to finalize and roll out
to staff. ENSURE COMPLIANCE: Monitor and ensure site compliance
with company, government and industry regulations, policies and
procedures, quality assurance guidelines and all federal, state and
local laws. Ensure compliance and maintain study-related
documentation requirements, including regulatory documents. Audit
operations to ensure compliance with protocol and applicable
regulations. Prepare for and coordinate all aspects of regulatory
agency site visits, including required paperwork.FOSTER
RELATIONSHIPS: Establish and maintain positive relationships with
external clinical/contract research organizations and clinical
study site. Build strong relationships with various persons
involved in studies, including but not limited to: patients,
relatives/friends of patients, doctors, pharmaceutical sponsors and
all levels of the company. Serve as a contact for principal
investigators and sub-investigators as needed an in the absence of
the President.MANAGE A HIGH PERFORMING TEAM: Recruit,
onboard/train, supervise and evaluate the performance of assigned
staff. Establish objectives and define results required for direct
reports in support of the strategic business goals. Coach, inspire
and enable staff to effectively perform and work with other
departments.QualificationsBachelor''s degree in business, a
clinical area or related field. Clinical knowledge
preferred.Minimum of five years of experience in business
operations management and ensuring ends goals are met. Experience
managing operations of clinical research studies a plus.Minimum of
two years of experience managing staff, including attracting,
training, establishing performance expectations and retaining top
talent.Familiarity with government compliance of clinical research
studies.Marketing experience including social media, Google
analytics and/or website administration.Experience analyzing and
implementing new technology.OTHER SKILLS AND ABILITIESHigh ethical
standards and professional integrity.Strong communications skills,
including verbal and written communication skills. Keeps supervisor
and others informed as appropriate.Collaborative nature and able to
quickly build trust.Excellent interpersonal skills that garner
cooperation from novative mindset.Process-oriented; develops and
updates processes to maximize efficiency and maintain
quality.Ability to quickly analyze situations and develop strong
solutions.Outstanding critical thinking and analytical anized and
able to multi-task well.Solid understanding of technology.Strong
negotiation skills.READY TO APPLY?If you are interested, qualified
and ready to take the next step, apply on-line at /careers. All
inquiries and resume submissions will be treated as strictly
confidential. Please do not contact Sundance Clinical Research
directly. Collaborative Strategies, Inc. is a St. Louis-based
consulting firm with a dedicated search practice and has been
connecting talent with opportunity since 1994. We take pride in
matching talented leaders seeking mission-critical endeavors with
entrepreneurial organizations. Visit us to view all of our current
opportunities and be sure to follow us on LinkedIn.- Equal
Opportunity Employer -
Keywords: Collaborative Strategies, St. Louis , Operations Manager with Sundance Clinical Research, Executive , Saint Louis, Missouri
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