• Bayer
  • $140,535.00 -83,300.00/year*
  • Whippany , NJ
  • Healthcare - Allied Health
  • Full-Time

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Apply online





Senior Study Lead Monitor - Women's Healthcare



Your tasks and responsibilities



The primary responsibilities of this role, Senior Study Lead
Monitor - Women's Healthcare, are to:





+ Leads and motivates the geographically dispersed Country
Lead Monitors (CLMs) and Clinical Research Associates (CRAs)
assigned to a given study.



+ Leads regular CLM meetings and contributes to regular
Core Team Meetings.



+ SLM works in close collaboration with the StM and the
Study Team.



+ Responsible for overseeing all operational aspects of
monitoring and site management activities for the assigned study.
This includes all operational aspects of conducting clinical
studies from the CLM/CRA, investigator and site staff perspective,
from site feasibility to study close out.



+ Manages the operational aspects of the site feasibility
to ensure study processes and expectations correspond to the
practicality of conducting the study from the operational
perspective, from site feasibility to study close out.



+ In case SLM is assigned to an out-sourced program under a
Partnership Operating Manual (POM), the SLM acts as an
'oversight manager'.



+ For outsourced studies (not under POM), the SLM is the
primary contact with CLMs, Country Head Site Management and Country
Medical Directors.



+ Ensures applicable information is cascaded in a timely
manner



+ Ensures required country review of applicable
documentation.



+ Reviews study specific Monitor and Investigator Site
Staff Training Plans and Investigator Meeting Approval Forms,
obtaining requisite functional and legal/compliance
approval.



+ Reviews Study Monitoring Plan, the relevant CRO plans and
ensures plans are consistent with Bayer expectations.



+ Conducts oversight as defined in the oversight plan.
Escalates operational issues or potential issues to StM as
applicable. Leads and coordinates assigned Country Lead Monitors
(CLM)



+ Represents monitoring and site management aspects in the
Core Study Team;



+ Works in close collaboration with the Country teams, StM,
Study Data Manager (SDM), EDC Developer, Study Medical Expert
(SME), IxRS and Medication Manager (IMM) and other
functions;



+ Works in a matrix organization and ensures consistent
information flow from Study Team to country teams and vice
versa;



+ Contributes to the study team goal setting
process



+ Responsible and accountable for the study specific
training and quality oversight of monitoring and site management
activities for the assigned study;



+ Specific activities related to the training include but
are not limited to:



+ Collaborates with StM on the CRA, CLM and site staff
relevant parts of the study specific Training Plan;



+ Obtains requisite functional and legal/compliance
approvals and coordinates activities related to global CRA and
Investigator Meetings;



+ Accountable for developing CLM/CRA training materials
Ensures study specific training of CLMs and CRAs;



+ Ensures all CLMs and CRAs assigned to the study have a
thorough understanding of the Monitoring Plan and study
expectations;



+ Coordinates development of site staff training material
for operational study activities;



+ Gives presentations as assigned at Investigator and/or
CRA Training;



+ Ensures proper tracking of monitoring and country
relevant topics and provides StM with information required to
accurately track and manage study activities;



+ Reviews Country Monthly Reports, tracks operational study
activities and progress, and consolidates information as required
by StM;



+ In partnership with SDM, tracks and manages patient data
review, verification and cleaning process to ensure continuous and
current flow of data cleaning;



+ Supports timeline planning from protocol stability level
1;



+ Responsible and accountable for developing the Monitoring
Plan and appendant study specific forms, and substantially
contributes to the development of recruitment and retention
strategies and tools;



+ Contributes to the protocol and study and oversight plan
development with regard to monitoring and operational
aspects;



+ Member of the Study Data Acquisition and Management
Package Development Team (SDAMP-DT) and works closely with the EDC
Developer in developing the eCRF, edit checks and eCRF
instructions;



+ Participates in system User Acceptance Testing as
required (e.g. IxRS, eCOA, eCRF), and coordinates system access for
country teams and site staff;



+ Contributes to standard workbook;



+ Conducts co-monitoring visits as specified in the study
oversight plan;



+ Reviews the monthly country report to identify country
issues and any operational study related trends;



+ Is an active member of the Fraud & Misconduct Team
and Serious Breach Team, as applicable;



+ Contributes to development of the Monitoring
Strategy;



+ Contributes to Study Risk levelling;



+ Proactively identifies potential issues;



+ Escalates identified issues appropriately to ensure
timely corrective and preventive actions are taken as
required;



+ Could be assigned as caretaker of the study risk profile
and ensures appropriate follow up of mitigation actions agreed at
KOMs and FU meetings;



+ Contributes to audit and inspection readiness of the
allocated study;



+ Contributes to audits and inspections and is responsible
to solve allocated tasks in the given timeframe;



+ Ensures all relevant IT-systems are updated with current
and accurate information (e.g. IMPACT);



+ Participates in expert working groups, project standard
teams etc.;



+ Contributes to global process improvement
efforts;



+ May act as a mentor to more junior colleagues or
mentees;



+ If SLM is assigned to an outsourced program under POM,
the SLM may act as an 'Oversight Manager' (OM). This is
an assignment not a job title. Dependent on the complexity and the
scope of the outsourced program, there might be more than one
Oversight Manager assigned. The distribution of tasks is clearly
defined and done based on the POM manual which is valid at time of
assignment. In that case no StM will be assigned and the Oversight
Manager will work directly with the GCMP and the Core study
team;



+ Oversight Manager is responsible for selected tasks for
the (e)-TMF which includes activities during set-up, Quality Check
and archiving according to Bayer processes;



+ Oversight manager has budget responsibilities as defined
in POM manual.













Who you are



Your success will be driven by your demonstration of our
LIFE values. More specifically related to this position,
Bayer seeks an incumbent who possesses the following:







Required Qualifications:









+ Bachelor's degree;



+ 8 years of Healthcare experience;



+ 4 years monitoring & site management
experience;



+ 2 years of Country Lead Monitor/country project
management experience;



+ 2 years of global clinical trial management;



+ In-depth knowledge of Good Clinical Practices (GCP) and
international regulations;



+ Ability to successfully achieve results within a
multi-cultural and geographically diverse team, and capability to
create team culture and promote team spirit.



+ Comprehensive knowledge of the drug development process
including monitoring and site management, regulatory requirements,
drug safety requirements, and data management
processes;



+ Effective written and verbal communication, thorough
knowledge of oral and written English, strong oral presentation,
and excellent interpersonal, decision-making and issue resolution
skills;



+ Effective planning and organization skills, attention to
detail and excellent follow through;



+ Manage conflicts in the team effectively.









#LI-US







Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the \"Passion to Innovate\" and the \"Power to Change\", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.













Bayer is an Equal Opportunity Employer/Disabled/Veterans







Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

















Country:United States

Location:NJ-Whippany

Functional Area:[sap_fa_16]

Entry Level:5
Associated topics: care physician, clinic, family practice, general practice, hospitalist, nocturnist, physician, practice physician, urgent, urgent care

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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