Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

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.

 

Domestic relocation assistance offered on this Role.

 

#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