Site Monitoring Lead II
Company: Innova Solutions
Location: Atlanta
Posted on: April 15, 2024
Job Description:
Innova Solutions is immediately hiring for a Site Monitoring
Lead IIPosition type: Full-time ContractDuration: 8 monthsLocation:
RemoteAs a Site Monitoring Lead II you will:JOB DESCRIPTIONPosition
Summary:The Senior Site Monitoring Lead (SML) is responsible for
partnering with the Lead Study Manager (LSM) to develop the
monitoring strategy for the study and will be the primary point of
contact for study-specific questions from both the internal and
where applicable CRO team for monitoring. The SML will support the
LSM in development, adherence and oversight to the monitoring
strategy and will escalate issues as applicable. The SML, where
assigned, will oversee Site Monitors (SM), ensuring consistency
across a study for monitor training, monitor report review,
monitoring oversight, and overall site monitor activities. The core
duties and responsibilities include, but are not limited
to:Responsibilities, as assigned:
- Responsible for study level management of SMs for clinical
study site/monitoring activities in compliance with ICH-GCP,
Sponsor SOPs, Local Laws & Regulations, Protocol, Clinical
Monitoring Plan, and associated documents.
- Conduct study start up activities where applicable at the site
level including but not limited to SQV, SIV (as applicable),
including management of issues that may compromise time to site
activation and/or initiation.
- Partners with CRO/monitor and Lead Study Manager (LSM) to
ensure site activation and support site monitoring readiness in
anticipation of first patient first visit.
- Support the LSM on monitoring oversight activities such as but
not limited to monitor selection, site selection and other
monitoring oversight activities as applicable.
- Assist LSM with creating and maintaining monitoring and/or
monitoring oversight plans and study specific tools/trackers (e.g.,
SM FAQ, ISF Reconciliation Tool and monitoring visit tracker).
- Facilitate and/or support the LSM with study wide SM trainings
and SM meetings.
- Reviews trip reports, tracks, and escalates risks to LSM.
- Provide LSM with feedback on individual SM progress at
sites.
- Support the LSM in the review, tracking and reporting of
monitoring and start-up metrics (e.g., CDA and contract status,
site and SM performance metrics).
- Co-monitoring as needed.
- May serve as SM at study sites depending on LSM delegation
and/or study needs as applicable.
- Support LSM in audit/inspection activities as needed.
- Facilitates and/or supports remote and on-site monitoring
activities, including training visits.
- Develops strong study team relationships with internal
stakeholders.
- Promote positive site relationships and ensure continuity
through all phases of the trial.
- Supports the LSM in reviews, and monitoring of required
regulatory documentation for study start-up, study maintenance and
study closeout.
- Supports LSM in risk and issue management, including
development of corrective and preventative actions, relevant to
site, SM, and vendor performance.
- Supports LSM in line listing data reviews and updating
site-facing data management documents.Requirements:
- BA/BS required, with preference for BA/BS with strong emphasis
in health or medical science or equivalent.
- Minimum of 5 years required of direct site monitoring
experience in a Biopharmaceutical, Pharmaceutical or CRO company,
or equivalent.
- Prior experience in oversight or management of site monitors,
management of global teams is preferred.
- Experience monitoring rare and ultra-rare disease, genetic
disease preferred. Monitoring metabolic disease, pediatric studies,
complex therapeutic studies such as Oncology, Cardiovascular,
Infectious Disease, Neurology, Transplant, etc. is a plus.
- Fluent in English and local languages where applicable (verbal
and written).
- Excellent communication skills and strong aptitude for conflict
resolution.
- Strong knowledge of GCP/ICH requirements, and ability to work
within country regulatory requirements and guidelines, as
applicable.
- Knowledge and application of Good Documentation Practices.
- Ability to conduct assessment of site performance and implement
effective corrective actions.
- Demonstrated high level of monitoring skill with independent
professional judgment.
- Proficient IT skills (Use of MS Office, use of various clinical
IT applications on computer, tablet, and mobile devices) and
ability to adapt to new IT applications on various devices.
- Ability to analyze data/metrics and act
appropriately.Behavioral Competency Expectations:
- Effective time management, organizational and interpersonal
skills, conflict management, problem solving skills.
- Works independently with high sense of accountability.
- Ability to create and modulate sense of urgency when needed and
as appropriate.
- Ability to set priorities and handle multiple tasks in a
changing environment.
- Works effectively in a matrix environment.Qualified candidates
should APPLY NOW for immediate consideration! Please hit APPLY to
provide the required information, and we will be back in touch as
soon as possible.We are currently interviewing to fill this and
other similar positions. If this role is not a fit for you, we do
offer a referral bonus program for referrals that we successfully
place with our clients, subject to program guidelines. ASK ME
HOW.Thank you!Preeti Sehgalpreeti.sehgal@innovasolutionscom PAY
RANGE AND BENEFITS:Pay Range*: $75 - $79/hr depending on experience
*Pay range offered to a successful candidate will be based on
several factors, including the candidate's education, work
experience, work location, specific job duties, certifications,
etc. Benefits: Innova Solutions offers benefits( based on
eligibility) that include the following: Medical & pharmacy
coverage, Dental/vision insurance, 401(k), Health saving account
(HSA) and Flexible spending account (FSA), Life Insurance, Pet
Insurance, Short term and Long term Disability, Accident & Critical
illness coverage, Pre-paid legal & ID theft protection, Sick time,
and other types of paid leaves (as required by law), Employee
Assistance Program (EAP).ABOUT INNOVA SOLUTIONS: Founded in 1998
and headquartered in Atlanta, Georgia, Innova Solutions employs
approximately 50,000 professionals worldwide and reports an annual
revenue approaching $3 Billion. Through our global delivery centers
across North America, Asia, and Europe, we deliver strategic
technology and business transformation solutions to our clients,
enabling them to operate as leaders within their fields. Recent
Recognitions:
- One of Largest IT Consulting Staffing firms in the USA -
Recognized as #4 by Staffing Industry Analysts (SIA 2022)
- ClearlyRated - Client Diamond Award Winner (2020)
- One of the Largest Certified MBE Companies in the NMSDC Network
(2022)
- Advanced Tier Services partner with AWS and Gold with
MSWebsite: Innova Solutions is an Equal Opportunity Employer and
prohibits any kind of unlawful discrimination and harassment.
Innova Solutions is committed to the principle of equal employment
opportunity for all employees and to providing employees with a
work environment free of discrimination and harassment on the basis
of race, color, religion or belief, national origin, citizenship,
social or ethnic origin, sex, age, physical or mental disability,
veteran status, marital status, domestic partner status, sexual
orientation, or any other status protected by the statutes, rules,
and regulations in the locations where it operates. If you are an
individual with a disability and need a reasonable accommodation to
assist with your job search or application for employment, please
contact us at or (770) 493-5588. Please indicate the specifics of
the assistance needed. Innova Solutions encourages all interested
and qualified candidates to apply for employment opportunities.
Innova Solutions (HireGenics/Volt) does not discriminate against
applicants based on citizenship status, immigration status, or
national origin, in accordance with 8 U.S.C. - 1324b.The company
will consider for employment qualified applicants with arrest and
conviction records in a manner that complies with the San Francisco
Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for
Hiring Ordinance, and other applicable laws.American Cybersystems,
Inc is acting as an Employment Agency in relation to this
vacancy.
Keywords: Innova Solutions, Atlanta , Site Monitoring Lead II, Other , Atlanta, Georgia
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