• Bayer
  • $91,060.00 -134,310.00/year*
  • Shrewsbury, MA
  • Scientific Research
  • Full-Time
  • 63 Edgewood Rd

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Principal Clinical Data Manager



Your tasks and responsibilities







The primary responsibilities of this role,
\"Principal Clinical Data Manager\" are
to:









+ Assume ownership and leadership for all Clinical Data
Management owned deliverables within assigned compound, project and
study and provide leadership to respective CDM staff, interfacing
function and team in order to support and achieve defined business
goals;



+ DM Expertise - Serve as the key subject matter expert on topics
related to data management activities including specific activities
and process in early clinical development phase;







+ Contribution include, but are not limited to - vendor selection
and management, mentoring junior staff, training team members,
leading or contributing to expert working groups (e.g., QSD
initiative), presenting best practices at internal and external
industry meetings meetings/congresses, and participating in due
diligence assessment;







+ PDM/EPDM tasks - Govern use of key data management element
across studies in assigned projects, assume ownership of
development and maintenance Medical Standards relevant to the area
of responsibility;







+ Contribute to data structure standards;



+ Review result of applied Important Medical Event (IME) List,
medical coding conventions;







+ Accountable or a contributor for CDM deliverables on study
and/or project level;



+ Ensure adequate application of Data Management Best Practice
across studies within assigned projects;



+ Review Study Team document for project consistency; ensure the
adequate documentation of all data management activities according
to SOP;



+ Provide governance and oversight for outsourcing activities by
providing input on budgetary items (e.g. RFP, vendor costing,
synergies, change orders, etc.), vendor selection and management,
risk and communication management, definition of deliverables,
Bayer-internal QC measures, progress tracking, and application of
best data management practices;



+ Advise on resource planning/allocation based on forecasted
activities per the Clinical Development Plan (CDP) and actual Key
Tasks and study/project metric;



+ Ensure CDM input and contribution to Risk Management (risk
identification, risk communication, incorporation of risk in risk
management plan, implementation of risk mitigation activities in
relevant plans);



+ Proactive DM specific project planning and tracking (timelines,
budget, risk assessment) of assigned projects from D3 to PoC and/or
to submission, fully aligned with the Statistics function (2-Lead
model) and the corresponding activities of the Early Clinical Team
and Clinical Project Team;



+ Ensure smooth phase-transitioning of project between research
and development phase in P&O, is instrumental to facilitate
data access and exchange between research and development
functions;



+ Organize state-of-the-art support for data-driven processes of
interfacing business functions like Pharmacovigilance department,
Pharmacokinetic department, Pharmacometrics department, and others
by ensuring timely and high quality Data Management input;



+ Establish data management best practices for data generated in
relevant research activities;



+ Actively support assessment of future trend to prepare for the
future, including personalized medicine, evidence based
re-imbursement, smart data storage, data insights, predictive and
probabilistic data management methods, digital studies, wearable
devices;



+ Engage actively in ongoing data review/reconciliation
activities and utilize dashboards, metrics and patient trackers to
monitor data arrival and clean up;



+ Shares data arrival and cleanup status and metrics with the
Study Team and Implementing Strategy;



+ Support the development and implementation of DMAR and/or OSBU
DM strategic initiatives and activities;



+ Contribute to projects and initiatives aimed at improving and
optimizing the delivery of DMAR. DS&A, Portfolio &
Operations, OSBU;



+ Ensuring Compliance, perform duties in compliance with SOPs,
GCP and ICH guidelines in accordance with regulatory, legal and
ethical standards;



+ Ensure complete, accurate and timely documentation for all
projects/studies according to established SOP.













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:









+ The incumbent possess a high skill and knowledge level in all
aspects of clinical data management in a clinical or research
environment;



+ The incumbent can lead a study or project data management team
independently;



+ The incumbent may lead complex projects, desire to improve best
practice, and is respected as a reliable partner in Clinical
Project Teams and Study Teams;



+ Bachelor's degree (or higher), preferably in the fields
of Natural Sciences, Life Sciences, Informatics, Medical
Documentation or related subjects; [Equivalent degrees such as
state certifications/graduations might also be accepted.];



+ At least 7 years of study and/or project level experience as a
Data Manager in supportive and leading roles;



+ At least 2 years of experience should demonstrate full
responsibility as the DM lead on studies/project(s);



+ Deep understanding of the drug development process;



+ Strong organizational skills and able to collaborate with
minimal supervision;



+ Ability to work and lead effectively in a global
environment;



+ Essential competencies identified include - Customer Focus,
Drive Results, Manage Complexity, Plans & Aligns;



+ Other key capabilities like Collaborates and Instills Trust
should be also displayed by the incumbent.









Preferred Qualifications:





+ Basic SAS Programming knowledge, or other database experience,
preferred;



+ Significant experience of using data management methodologies
and technologies (e.g., electronic data capture, familiar with data
warehousing);



+ Demonstrated understanding of regulations and guidelines (e.g.
ICH, GCP, European Clinical Trials Directive, Privacy rules
[HIPPA]);



+ The incumbent is required to conduct him/herself in an
appropriate business manner adhering to a high ethical
standard.





















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: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, MA-Norwood, MA-Sheffield, MA-South Deerfield, MA-Cambridge, MA-Boston, MA-Bridgewater, MA-Framingham, MA-Reading, MA-Shrewsbury, 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, MD-College Park, MD-Gaithersburg, MD-Glen Burnie, MD-Silver Spring, MD-Towson, MD-Waldorf, GA-Dawson, MA-Springfield, MD-Baltimore, Residence Based, Residence Based, Residence Based, GA-Cartersville, GA-Tifton, MD-Galena
Associated topics: data analyst, data analytic, data architect, data integrity, data quality, data scientist, data warehousing, erp, mongo database administrator, sql

* 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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