• Bayer
  • $131,430.00 -199,650.00/year*
  • Montville, NJ
  • Government
  • Full-Time
  • 29 Schneider Ln

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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.

Apply online

Deputy Director

Your tasks and responsibilities

The primary responsibilities of this role, Deputy Director, are

+ Directly manage and develop 8-12 staff combined of Clinical
Lead Monitor (CLM), Clinical Research Associate (CRA)/Senior
Clinical Research Associate/SrCRA and /or Managers of Monitoring
and/or Team Leaders;

+ Assure hiring, training, development, compensation and
advancement are in line with talent and job expectations;

+ Routinely assess talent for direct reports to ensure full

+ Provide expertise, strong leadership and management to direct
reports and maintain a motivated and competent staff;

+ Ensure projects/studies are properly and strategically
resourced by allocating or hiring the appropriate staff to deliver
relevant goals and by critically analyzing project/study needs and
managing/measuring the workload and requirements of direct reports.
These activities are done in close alignment with GSM CH /RH and

+ Be accountable that all monitoring and site
management procedures and activities are conducted according to
ICH-GCP, Declaration of Helsinki, local and global requirements of
applicable Phase I -IV clinical trials, remaining current with
local laws, regulations and guide lines. This includes country
feasibility, site selection, site initiation, patient enrollment,
patient adverse event reporting and data cleaning processes direct
reports are responsible for assuring that each direct report
delivers high quality study data required to support regulatory
submissions in compliance with ethical and global operating

+ Through effective management and development of direct reports
(including insourced staff through vendors), be accountable that
country's objectives are met, providing direct reports with
the resources to achieve his/her objectives and commitments;

+ Be responsible for managing internal costs associated with
direct reports (including insourced staff), and contributes in
preparation tracking and meeting of the overall departmental
operating budget target;

+ Ensure CLM provide accurate data for External Clinical

+ Review External Clinical Grants data to ensure budgeting
components are within the approved budget parameters, as well as
ensuring accuracy, equity and supporting the CLM in resolving any

+ Ensure Quality Oversight based on quality risk indicators and
Key Performance Indicator(KPI )and oversee Corrective Actions /
Preventive Actions (CAPAs) of direct reports to ensure timely and
sufficient resolution;

+ Conduct/Coordinate Performance Assessment Visits to ensure CRA
are trained appropriately and to identify potential training or
development needs;

+ Participate in Audit Review Meetings and coordinate and review
all responses to audit findings prior to submission;

+ Proactively identify actions to be taken at the country level
to improve upon audit and inspection findings;

+ Actively support Sponsor regulatory inspection in cooperation
with CH/RH;

+ Supports CH/RH with follow-up of all Regulatory Inspections,
Regulatory concerns related to investigator integrity, GCP and the
veracity of all clinical data in New Drug Application(NDA), Common
Technical Documents(CTD), PLA, SNDA and Invesgative New
Drug( IND) submissions;

+ Continuously and proactively identify and propose solutions for
process improvement opportunities to CH/RH GSM, and communicate
best practices to entire monitoring staff;

+ Lead or participate in local and international Expert
Working Groups, provides feedback during Standard Operating
Procedure( SOP) review;

+ Develop and implement strategies to engage and influence
external stakeholders at all levels (Principle Investigators,
Institution, Government) to develop the territories and establish
positive and competitive environment for clinical trials (cost
effectiveness, recruitment strategies speed of trials);

+ Collaborate with Medical Affairs and commercial Business Units
and other pertinent local functions to cultivate and enhance
clinical investigator taught Leader relationships to ensure that
Bayer is the sponsor of choice as well as to support business

+ Assess all training needs for permanent and insourced staff,
develop and implement training and development plan in a timely

+ Align local training needs and best practices with GCDO
Training strategy;

+ Contribute to delivering Training programs developed by GCDO
ICH-GCP Training. Require thorough understanding of GCD global and
local processes and associated Global Standard Operating procedures

+ Ensure country oversight, engagement and partnership of CRO for
outsourced studies ensuring CRO's adherence to country legal
requirements and operational agreements;

+ Periodically cover the GSM CH/RH deputy role.

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 at least 9 years healthcare
experience including at least 5 years clinical development or
clinical operations experience;

+ In-depth knowledge of clinical development and drug development
process, global clinical development processes, ICH-GCP, applicable
legal, compliance and regulatory requirements;

+ Leadership, motivational, and collaborative skill;

+ Ability to lead staff in changing times as well as strong
interpersonal skills and at least 5 years experience in the
management and development of people;

+ Administrative, financial, and technical skills, as well as
effective verbal and written English communication skills in
relation to both internal and external colleagues;

+ Able to work effectively within a multi-cultural, global,
matrix organization.

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, 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, DE-Dover, DE-Wilmington, MD-College Park, MD-Gaithersburg, MD-Glen Burnie, MD-Silver Spring, MD-Towson, MD-Waldorf, OH-Akron, OH-Cincinnati, OH-Cleveland, OH-Columbus, OH-Dayton, OH-Hamilton, OH-Lebanon, OH-Reynoldsburg, OH-Toledo, RI-Providence, VA-Chantilly, VA-Chesterfield, VA-Fairfax, VA-Fredericksburg, VA-Hampton, VA-Richmond, VA-Virginia Beach, NC-Cary, AL-Mobile, CT-Stamford, GA-Dawson, MA-Springfield, MD-Baltimore, NY-Bronx, NY-Brooklyn, NY-Buffalo, NY-Syracuse, NY-White Plains, PA-Reading, PA-Scranton, RI-Cumberland, RI-Woonsocket, 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, 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, IN-Windfall, MD-Galena, MI-Constantine, MI-Kalamazoo, MI-Mason, MI-Richland, NC-Kannapolis, NC-Mount Olive, NC-Mt Olive, 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
Associated topics: ambulatory, care unit, infectious, internal medicine, medical, medicaion, operating room nurse, registered nurse, therapist, vm 0602 00

* 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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