• Bayer AG
  • $106,390.00 -159,250.00/year*
  • Whippany , NJ
  • Scientific Research
  • Full-Time

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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. 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.
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Apply online

Principal Clinical Data Manager

Your tasks and responsibilities

The primary responsibilities of this role, Principal Clinical Data Manager, are to:
* Data Management Expertise:
* Serves as the key subject matter expert on topics related to data management activities.
* Contributions include, but are not limited: vendor selection and management, mentoring junior staff, training team members, leading or contributing to expert working groups (e.g., SOPs,OM's, PGDs, etc.), presenting best practices at internal and external industry meetings meetings/congresses, and participating in due diligence assessments.
* Principal Data Manager Tasks:
* Governs use of key data management elements across studies in assigned project: assumes ownership of development and maintenance Medical Standards relevant to the area of responsibility (GMS/TAS/CPS/Codelists); provides data structure standards; review application of the Important Medical Event (IME) List, medical coding conventions, and standard coding rules;
* Ensures adequate application of Data Management Best Practices across studies within assigned project: review Study Team documents for project consistency; ensure the adequate documentation of all data management activities according to SOPs;
* Provides 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, and application of best data management practices;
* Implementing Strategy:
* Supports the development and implementation of Project and Study Data Management strategic initiatives and activities;
* Contributes to projects and initiatives aimed at improving and optimizing the delivery of Project and Study Data Management, GDM and GCO services;
* Ensuring Compliance:
* Performs duties in compliance with SOPs, GCP and ICH guidelines in accordance with regulatory, legal and ethical standards;
* Ensures complete, accurate and timely documentation for all projects/studies according to established SOPs, Operational Instructions (OIs) and Process Guidance Documents (PGDs);
* Tracks and leads project-level data management activities: manage PDM Teams efficiently; ensures the timely delivery of high-quality study databases and smooth operation of SDM teams; identify issues, define and direct resolution measures; reports progress and escalate issues into management;
* Represents GDM as the Core Study Team member for internal and outsourced studies, and coordinates the SDM Team in any aspect;
* Manages cross-functional team memberships and interfaces effectively: serves as GDM member of the core Global Clinical Team;
* Works closely with clinical and safety experts in the definition, preparation and review of reports that are critical to ensuring the quality, accuracy and completeness of analyses on study safety, medical coding and Global Pharmacovigilance data;
* Develops robust and productive relationships with internal and external business partners: treats others fairly and with respect;
* Manage conflicts constructively;
* Provide timely and relevant feedback.

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;
* 7 years of study and/or project level experience as a Data Manager in supportive and leading roles;
* 2 years of experience should demonstrate responsibility as the DM lead on studies/projects;
* Deep understanding of the drug development process;
* Strong organizational skills and able to collaborate with minimal supervision
* Significant experience of using data management methodologies and technologies (e.g. data warehousing, electronic data capture);
* 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.

Preferred Qualifications:

* Basic SAS Programming knowledge, or other database experience.

#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_28]
Entry Level: 5
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Apply online* Bachelor's degree; * 7 years of study and/or project level experience as a Data Manager in supportive and leading roles; * 2 years of experience should demonstrate responsibility as the DM lead on studies/projects; * Deep understanding of the drug development process; * Strong organizational skills and able to collaborate with minimal supervision * Significant experience of using data management methodologies and technologies (e.g. data warehousing, electronic data capture); * 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. Preferred Qualifications: * Basic SAS Programming knowledge, or other database experience. #LI-USBayer 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.
Associated topics: data engineer, data integration, data integrity, data manager, data quality, data scientist, data warehouse, erp, hbase, sybase
Associated topics: data analyst, data analytic, data center, data quality, data scientist, database, hbase, mongo database, sql, teradata

* 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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