FSP Manager, Global Clinical Monitoring
Company: Precision Medicine Group
Location: Houston
Posted on: October 14, 2024
Job Description:
FSP Manager, Global Clinical Monitoring
at Precision Medicine Group (View all jobs)
Remote, United States
Position Summary:
- The FSP Manager Global Clinical Monitoring (GCM) offers an
additional development path for clinical research professionals.
Responsibilities are focused on the management and career
development of the organization's Clinical Research Associate (CRA)
workforce as well as providing oversight and coordination of
project activities for CRAs assigned to FSP partnership.
- This position requires the ability to independently lead,
manage, and motivate a team of CRAs to a standard consistent with
Precision for Medicine's values and overall focus on quality. In
addition, this position will provide the CRAs with career
development and support, to minimize turnover and maintain high
levels of employee satisfaction.
Essential functions of the job include but are not limited to:
- Generate action plans and provide developmental/strategic
oversight to optimize CRA services, with a focus on high quality
delivery of individual/team/departmental goals.
- Assist with and contribute to project resourcing to ensure
proper level and allocation resource is assigned for each project
within the FSP work order. Update tracking systems and interface
with project teams.
- Collaborate with the FSP Oversight Director and Clinical
Operations Management Team to ensure that resource needs and site
requirements are met appropriately.
- Develop, mentor, manage and coach CRA staff to progress their
skills so that Precision for Medicine quality standards are
maintained. Advocate individual career development, and individual
responsibility/accountability.
- Perform accompanied site visits to assess CRA skills and
developmental needs, as well as assist CRAs with project specific
issues.
- Identify quality risks and issues and recommend corrective
action plans as needed to address deficiencies in performance of
employees.
- Ensure that all staff have the proper resources, training,
materials, and access to systems to deliver on the expectations of
their position.
- Ensure CRAs provide timely and accurate updates of all required
administrative material (SOPs, T&E, etc.) on company
systems.
- Work with the Clinical Operations Management Team to
continually improve and enhance CRA expectations and procedures to
promote quality, consistency and efficiency in execution.
- Develop and maintain metrics pertinent to CRA resource
oversight, and work with Clinical Operations Management Team on the
evaluation of these metrics.
- Participate in the interview process for new CRAs by conducting
CV review and participating in the interviewing process.
- Conduct on-boarding training for new CRA staff in conjunction
with Human Resources, Clinical Training, and other functional
areas, including sponsor specific training requirements.
- Represent Precision for Medicine in a professional manner.
- Manage CRA staff in accordance with Precision for Medicine's
values and policies.
- Review and approve all visit reports, timecards, and expense
reports for assigned CRAs.
- Ensure monitoring visits are performed in accordance with
monitoring plan.
- Provide oversight of CRA project performance including eTMF
completion and quality, SDV completion, and query/issue closure
timeliness.
- Attend investigator meetings and regular internal / sponsor
meetings to discuss study progress and team performance.
- Provide oversight of Study Start-up Team to ensure sites
progress from selection to initiation visit on-time and in
agreement with sponsor expectations.
- Support CRAs and Study Start-up with ICF customization and
version tracking.
- Ensure study systems and trackers are kept up to date.
- Planning, assigning, and directing of work as well as gathering
performance feedback to contribute to appropriate action
plans.
- Perform other duties as assigned by Leadership.
Qualifications:
Minimum Required :
- Graduate, postgraduate, 4-year college degree, or equivalent
experience ideally in a scientific or healthcare discipline
Other Required:
- At least 7 years or more in clinical operations, data
management or related discipline either in CRO or Pharmaceutical
industry with a minimum of 5 years onsite monitoring
experience.
- Ability to drive and availability for domestic and
international travel including overnight stays, with an expectation
of travel approximately 25%.
Preferred:
- Experience in the Therapeutic area/country of the staff
assigned to manage.
Skills/Competencies:
- Demonstrates mastery knowledge of ICH-GCP, applicable local
regulatory requirements technical CRA knowledge of all phases of
study (including remote monitoring and clinical data review) as
well as regulatory guidance.
- High capacity for Emotional Intelligence and a passion for
people management and development.
- As part of overall line management responsibilities, ability to
develop training plans and hold personnel accountable to achieving
training goals or addressing training needs.
- Deep knowledge of how clinical research centers operate along
with the ability to teach CRAs to solve site and execution related
problems at the site level.
- Demonstrates understanding and ability to work with EMRs and
EDCs
- Exhibits high self-motivation and can work and plan
independently as well as in a team environment.
- Motivates other members of the project team to meet timelines
and project goals.
- Highly organized, ability to set priorities and possesses
excellent problem-solving skills.
- Focuses on continuous improvement, including the ability to
make proactive assessments on how to make processes more efficient
and people more effective.
- Understands clinical trials methodology, including a working
knowledge of protocols and indications being studied.
- Ability to develop, coach and mentor CRA staff.
- Demonstrates a high degree of professionalism, as evidenced by
punctuality, ability to deliver on commitments, an understanding of
the service culture and positive interactions with customers and
teammates, including good interpersonal skills.
- Communicates both verbally and in written form in an acceptable
manner.
- Conducts formal presentations to a wide variety of audiences
including colleagues, investigative staff, and clients with a high
level of proficiency.
- Possesses practical knowledge of IT tools and systems in use on
project teams.
- Values system and work ethic consistent with Precision Values
and Company Principles
Precision is required by law in some states or cities to include a
reasonable estimate of the compensation range for this role. This
compensation range takes into account the wide range of factors
that are considered in making compensation decisions including but
not limited to: skill sets, experience and training, licensure and
certifications, and other business and organizational needs. The
disclosed range estimate has not been adjusted for the applicable
geographic differential associated with the location at which the
position may be filled. At Precision, it is not typical for an
individual to be hired at or near the top of the range for their
role and compensation decisions are dependent on the facts and
circumstances of each case. This role is also eligible for a
discretionary annual bonus, health insurance, retirement savings
benefits, life insurance and disability benefits, parental leave,
and paid time off for sick leave and vacation, among other
benefits.
Reasonable estimate of the current range
$121,000 - $163,800 USD
Any data provided as a part of this application will be stored in
accordance with our Privacy Policy. For CA applicants, please also
refer to our CA Privacy Notice .
Precision Medicine Group is an Equal Opportunity Employer.
Employment decisions are made without regard to race, color, age,
religion, sex, sexual orientation, gender identity, national
origin, disability, veteran status or other characteristics
protected by law. - 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable
accommodation to complete any part of the application process or
are limited in the ability or unable to access or use this online
application process and need an alternative method for applying,
you may contact Precision Medicine Group at
QuestionForHR@precisionmedicinegrp.com .
It has come to our attention that some individuals or organizations
are reaching out to job seekers and posing as potential employers
presenting enticing employment offers. We want to emphasize that
these offers are not associated with our company and may be
fraudulent in nature. Please note that our organization will not
extend a job offer without prior communication with our recruiting
team, hiring managers and a formal interview process.
Keywords: Precision Medicine Group, Pearland , FSP Manager, Global Clinical Monitoring, Executive , Houston, Texas
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