• Bayer
  • Education - Excluding Post Secondary
  • Full-Time

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Study Lead Monitor



Your tasks and responsibilities







The primary responsibilities of this role,Study Lead
Monitor,are to:









+ Lead and motivate the geographically dispersed Country Lead
Monitor (CLM) and Clinical Research Associate (CRA) assigned to a
given study;



+ Lead regular CLM meetings and contribute to regular Core Team
Meetings;



+ As a core member of the Study Team, the SLM works in close
collaboration with the STM and the Study Team;



+ As the competent team member on monitoring and site management
in the Core Study Team, SLM is responsible for overseeing all
operational aspects of monitoring and site management activities
for the assigned study, this includes all operational aspect of
conducting clinical studies from the CLM/CRA, Investigator and site
staff perspective, from site feasibility to study close out;



+ Manage the operational aspect of the site feasibility to ensure
study process and expectation correspond to the practicality of
conducting the study from the operational perspective, from site
feasibility to study close out;



+ The 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 CLM, Country Head Site Management and Country Medical
Directors:



+ Ensure applicable information is cascaded in a timely
manner;



+ Ensure 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;



+ Review Study Monitoring Plan, the relevant CRO plans and ensure
plans are consistent with Bayer expectations;



+ Conduct oversight as defined in the oversight plan and escalate
operational issues or potential issues to STM as applicable;



+ Lead and coordinate assigned Country Lead Monitors (CLM);















+ COLLABORATION and CONTRIBUTION







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



+ Work 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;



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



+ Contribute to the study team goal setting process;











+ TRAINING







+ 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:



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



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



+ Accountable for developing CLM/CRA training materials;



+ Ensure study specific training of CLM and CRA;



+ Ensure all CLM and CRA assigned to the study have a thorough
understanding of the Monitoring Plan and study expectation;



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



+ Give presentation as assigned at Investigator and/or CRA
Training;















+ TRACKING AND REPORTING







+ As a Core Team Member of the Global Study Team (GST), SLM
ensures proper tracking of monitoring and country relevant topics
and provides STM with information required to accurately track and
manage study activities;



+ Review Country Monthly Reports, track operational study
activities and progress, and consolidate information as required by
STM;



+ Partnership with SDM, track and manage patient data review,
verification and cleaning process to ensure continuous and current
flow of data cleaning;



+ Support timeline planning from protocol stability level 1;











+ PREPARATION OF DOCUMENTS







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



+ Contribute to the protocol, 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 work closely with the EDC Developer
in developing the eCRF, edit checks and eCRF instructions;



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



+ Contribute to standard workbook;











+ QUALITY, RISK IDENTIFICATION AND HANDLING







+ Conduct co-monitoring visit as specified in the study oversight
plan;



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



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



+ Contribute to development of the Monitoring Strategy;



+ Contributes to Study Risk levelling;



+ Proactively identifies potential issues;



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



+ Contribute to audit and inspection readiness of the allocated
study, audit and inspection and is responsible to solve allocated
tasks in the given timeframe;











+ SYSTEM MAINTAINANCE AND CONTINOUS IMPROVEMENT







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













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 with 5 years of Healthcare experience
including 4 years monitoring & site management experience and 2
years of CLM/country project management experience;



+ As the expert of monitoring and site management processes and
activities on the global study team, this position requires
in-depth knowledge of Good Clinical Practices (GCP) and
international regulations;



+ The position also requires ability to successfully achieve
results within a multi-cultural and geographically diverse team,
and capability to create team culture and promote team spirit;



+ The incumbent require comprehensive knowledge of the drug
development process including monitoring and site management,
regulatory requirement, drug safety requirements, and data
management process;



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



+ In addition, the incumbent require effective planning and
organization skills, attention to detail and excellent follow
through;



+ The SLM is able to manage conflicts in the team
effectively.









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:AL-Birmingham, AL-Huntsville, CT-Bristol, CT-Hartford, CT-New Haven, CT-West Haven, DC-Washington, FL-Bradenton, FL-Cape Coral, FL-Daytona Beach, FL-Destin, FL-Fort Lauderdale, FL-Ft Myers, FL-Gainesville, FL-Jacksonville, FL-Kissimmee, FL-Lakeland, FL-Miami, FL-Tampa, FL-Naples, FL-Ocala, FL-Orange Park, FL-Orlando, FL-Pensacola, FL-Port St Lucie, FL-Molino, FL-St. Petersburg, FL-West Palm Beach, GA-Chatsworth, GA-Leesburg, GA-Woodbine, GA-Alpharetta, GA-Atlanta, GA-Augusta, GA-Duluth, GA-Forest Park, GA-Gainesville, GA-Kennesaw, GA-Lawrenceville, GA-Macon, GA-Marietta, GA-North Atlanta, GA-Peachtree City, GA-Savannah, GA-South Atlanta, GA-Tucker, IL-Champaign, IL-Rolling Meadows, IL-Collinsville, IL-Elgin, IL-Elk Grove Village, IL-Naperville, IL-Niles, IL-Oak Grove, IL-Calumet City, IL-Chicago, IN-Edison Lakes, IN-Elkhart, IN-Mishawaka, IN-Carmel, IN-Fort Wayne, IN-Indianapolis, IA-Earlham, KS-Shawnee Mission, KS-Topeka, KS-Wichita, KS-Stilwell, MA-Norwood, MA-Sheffield, MA-South Deerfield, MA-Cambridge, MA-Boston, MA-Bridgewater, MA-Framingham, MA-Reading, MA-Shrewsbury, MI-Muskegon, MI-Clinton Twp, MI-Grand Rapids, MI-Madison Heights, MI-North Detroit, MI-South Bend, MI-South Detroit, MI-Ypsilanti, MI-Flint, NJ-Cedar Knolls, NJ-Fairfield, NJ-Montville, NJ-Morristown, NJ-Parsippany, Residence Based, NJ-Wayne, NJ-Whippany, NJ-Paterson, NJ-Trenton, NJ-Cherry Hill, NJ-Egg Harbor Twp, NJ-Jersey City, NJ-Lakewood, NJ-Old Bridge, NY-Tarrytown, NY-Albany, NY-Commack, NY-Garden City, NY-Long Island, NY-Manhattan, NY-Newburgh, NY-Queens, NY-Rochester, NY-Staten Island, NC-Morrisville, NC-Pikeville, NC-Research Triangle Park, Residence Based, NC-Wilson, NC-Asheville, NC-Chapel Hill, NC-Charlotte, NC-Durham, NC-Fayetteville, NC-Gastonia, NC-Greensboro, NC-Hickory, NC-Matthews, NC-Raleigh, NC-Statesville, NC-Clayton, NC-Wilmington, NC-Winston-Salem, PA-Indianola, PA-Myerstown, PA-Pittsburgh, PA-Pittsburgh Heilman, Residence Based, PA-Saxonburg, PA-Warrendale, PA-Allentown, PA-Bensalem, PA-Drexel Hill, PA-Lancaster, PA-Norristown, PA-Philadelphia, PA-Pottstown, PA-Wilkes Barre, PA-York, PA-Harrisburg, PA-West Chester, SC-Spartanburg, SC-Myrtle Beach, SC-Charleston, SC-Columbia, SC-Greenville, TN-Charleston, TN-Cleveland, TN-Memphis, TN-Brentwood, TN-Chattanooga, TN-Hendersonville, TN-Johnson City, TN-Knoxville, TN-Nashville, WA-Issaquah, WA-Tacoma, WA-Spokane, WA-SeaTac, WA-Kennewick, WA-Bremerton, WA-Bothell, WA-Lynnwood, WA-Seattle, WV-Institute, WV-New Martinsville, WV-South Charleston, WV-Weirton, DE-Dover, DE-Wilmington, ID-Boise, ID-Parma, KY-Lexington, KY-Louisville, LA-Baton Rouge, LA-New Orleans, MD-College Park, MD-Gaithersburg, MD-Glen Burnie, MD-Silver Spring, MD-Towson, MD-Waldorf, NH-Manchester, ND-Minot, NM-Albuquerque, OH-Akron, OH-Cincinnati, OH-Cleveland, OH-Columbus, OH-Dayton, OH-Hamilton, OH-Lebanon, OH-Reynoldsburg, OH-Toledo, RI-Providence, UT-Clearfield, UT-Layton, UT-Salt Lake City, UT-Sandy, VT-Burlington, VA-Chantilly, VA-Chesterfield, VA-Fairfax, VA-Fredericksburg, VA-Hampton, VA-Richmond, VA-Virginia Beach, NC-Cary, AL-Mobile, CT-Stamford, GA-Dawson, IA-Des Moines, KS-Kansas City, LA-Lafayette, LA-Shreveport, MA-Springfield, MD-Baltimore, NY-Bronx, NY-Brooklyn, NY-Buffalo, NY-Syracuse, NY-White Plains, PA-Reading, PA-Scranton, RI-Cumberland, RI-Woonsocket, WV-Charleston, Residence Based, Residence Based, Residence Based, Residence Based, Residence Based, Residence Based, Residence Based, Residence Based, Residence Based, Residence Based, Residence Based, Residence Based, Residence Based, Residence Based, Residence Based, Residence Based, Residence Based, Residence Based, Residence Based, Residence Based, Residence Based, Residence Based, Residence Based, Residence Based, Residence Based, Residence Based, Residence Based, Residence Based, AL-Centre, AL-Loxley, AL-Piedmont, CT-Mystic, FL-Felda, FL-Homestead, FL-LaBelle, FL-Plant City, GA-Cartersville, GA-Tifton, IA-Anamosa, IA-Ankeny, IA-Aplington, IA-Atlantic, IA-Beaman, IA-Boone, IA-Carroll, IA-Cedar Rapids, IA-Clarion, IA-Dyke, IA-Grinnell, IA-Harcourt, IA-Harlan, IA-Humboldt, IA-Huxley, IA-Independence, IA-Muscatine, IA-North Liberty, IA-Oelwein, IA-Pella, IA-Perry, IA-Spencer, IA-Storm Lake, IA-Urbandale, IA-Williamsburg, ID-Filer, ID-Nampa, ID-Payette, ID-Soda Springs, ID-Williamsburg, IL-Ashton, IL-Bloomington, IL-Centralia, IL-Dekalb, IL-Dwight, IL-Effingham, IL-Fairmount, IL-Farmer City, IL-Geneseo, IL-Illiopolis, IL-Jerseyville, IL-Lexington, IL-Mason City, IL-Milford, IL-Monmouth, IL-Morton, IL-Morton Grove, IL-Moweaqua, IL-Pleasant Plains, IL-Savoy, IL-Skokie, IL-Stonington, IL-Thomasboro, IL-Tremont, IL-Tuscola, IL-Ursa, IL-Waterman, IN-Brazil, IN-Cicero, IN-Crawfordsville, IN-Evansville, IN-Franklin, IN-Greensburg, IN-Kentland, IN-Lafayette, IN-Lebanon, IN-Monticello, IN-New Castle, IN-Oxford, IN-Remington, IN-Rensselaer, IN-Reynolds, IN-Tipton, IN-Washington, IN-West Lafayette, IN-Whitestown, 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Hope, KS-Plains, KS-Ulysses, LA-Luling, MD-Galena, MI-Constantine, MI-Kalamazoo, MI-Mason, MI-Richland, NC-Kannapolis, NC-Mount Olive, NC-Mt Olive, ND-Fargo, ND-West Fargo, NM-Berino, NM-Las Cruces, NY-Canandiagua, OH-Deshler, OH-Findlay, OH-Greenville, OH-London, OH-Marion, OH-St Marys, OH-Troy, OH-Washington Courthouse, PA-Manheim, SC-Greenwood, SC-Hartsville, TN-Cordova, TN-Franklin, TN-Union City, WA-LaConner, WA-Othello, WA-Warden
Associated topics: administrative, administrative assistant, administrative support, assist, counsel, elementary school counselor, guidance counselor, receptionist, secretary, speech language pathologist

* 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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