At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

 

Clinical Data Manager 

 

Position Purpose:

The Clinical Data Manager (CDM) leads and/or supports the execution of data management activities necessary for the preparation of submission data and required documentation for regulatory authorities and the greater clinical research community. The CDM may assume the business role of a Study Data Manager in studies with standard complexity. In this capacity, s/he serves as the primary contact for Data Management on the Core Study Team. The SDM leads the SDM team, which is comprised of several Extended Study Team members, to ensure data management deliverables meet, or exceed, corporate and industry quality standards in a timely and cost efficient manner. This potentially includes the co-accountability with the Statistics Lead to create, maintain and manage the Project Plan.

The CDM may support SDMs for complex trials to ensure completion of tasks in a timely manner at high quality.

 

Scope: Global

 

Major tasks and responsabilities:

 

 

DM Expertise

 

Serves as the subject matter expert on topics related to data management activities. Contributions include, but are not limited to: vendor selection and management, mentoring junior staff, training team members, contributing to expert working groups (e.g., QSD initiatives), presenting best practices at internal and external industry meetings meetings/congresses.

 

SDM tasks

Assumes operational and/or oversight responsibility as Study Data Manager for all assigned internal and outsourced studies, and apply Data Management best practices.Accountable or a contributor for CDM deliverables from protocol creation until release of data for analysis.Ensure CDM input and contributions to Risk Management (risk identification, risk communication, incorporation of risk in risk management plan, implementation of risk mitigation activities in relevant plans)Incorporates and maintains Medical Standards in clinical studie for all elements of the medical standards package.Documents all activities adequately for all assigned studies according to SOPs and takes a lead role in QC activities, which includes, but is not limited to: initiating the documentation, maintaining document management systems, coordinating and ensuring contributions from relevant functions, requesting a timely QC of the documentation, informing relevant functions of results and ensuring proper communication between functions, QC manager and self so that all issues are reconciled.Specifies and develops study specific eCRFs, data consistency checks based on Medical Standards, the Clinical Study Protocol and input from the study team, contributes to the database structure.Contributes or drives preparation, tracking and implementation of standard plans (i.e., Project Plan, Data Management Plan, Operational Oversight Plan, etc.) to ensure proper governance of data management study set-up, conduct and closure activities.Accountable for or contributes to data management activities necessary for the establishment of subject validity and analysis set assignment, including but not limited to the following: specification of important deviations and validity findings, planning and conduct of interim and final Blind Review Meetings, preparation and completion of the final Blind Review Report.Engages actively in ongoing data review/reconciliation activities and utilizes dashboards, metrics and patient trackers to monitor data arrival and clean up.  Shares data arrival and cleanup status and metrics with the Study TeamAs applicable, plans and tracks data contributions of specialized functions typically used for early clinical development activities like Pharmacokinetics, Biomarker, Bioinformatics, Pharmacometrics, as well as strategic operational partners.As applicable, establishes data management best practices for data generated in relevant research activities which may be needed in later project activities like decision making processes and submissions. This includes but is not limited to the following: support of setting data standards compatible with Bayer development standards, support of central storage and inventory, supporting data transfer activities from external vendors, supporting integration with data generated in clinical phases of development.

 

Operational Data Management

 

Supports or drives study data management and data cleaning processes on an ongoing basis, applying study specific documents and conventions.Identifies and issue queries, incorporates query replies and tracks query status.

 

Implementing Strategy

 

Contributes to projects and initiatives aimed at improving and optimizing the delivery of DMAR and CDM, OSBU DM.

 

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.

 

Value added:

 

Clinical trials data management is a highly regulated and compliance driven environment. The timely delivery of high quality data is directly linked to the extent that the company can make decisions on continuation of development programs, or that the company can claim, and prove its portfolio assets are safe, effective and marketable. The Clinical Data Manager is supports or is responsible for the consistency in support, planning and delivery of data management deliverables in assigned studies, projects (if applicable), or research activities. S/he is contributing to the development and sharing of best DM practices. These efforts cascade throughout the supported research and drug development value chain.

 

Work Interactions:

 

Represents CDM as the Core Study Team member for internal and outsourced studies, and coordinates the DM Team in any aspect.Contributes to cross-functional teams and interfaces effectively: serves as CDM member of the core Clinical Team or Early Clinical Team (as applicable).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 Pharmacovigilance data.Establishes and tracks data management activities in co-operation with Pharmacokinetic department and Pharmacometrics department, with internal research functions like Biomarker and Bioinformatics, and with strategic external partners.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.

 

Qualifications & Experience:

 

 

The incumbent possesses a high skill and knowledge level in all aspects of clinical data management. The incumbent can lead a clinical data management team independently. The incumbent may lead standard complex studies to improve best practices and is respected as a reliable partner in Study Teams.

 

Bachelor’s degree (or equivalent/higher), preferably in the fields of Natural Sciences, Life Sciences, Informatics, Medical Documentation or related subject;        
[Equivalent degrees like state certifications/graduations might also be accepted; relevant work experience might be acceptable instead of a degree, where equivalent is defined as a minimum of 7 years of relevant Data Management related experience in research or development.] (not applicable for the Oncology Business Unit)At least 3 years of study level experience as a Data Manager in supportive and leading roles, or as a project-leading role in a scientific, data-driven position in the medical research area.Good understanding of the drug development process, understanding of relevant research processes.Strong organizational skills and able to collaborate with limited supervision.Broad experience in using data management methodologies and technologies (e.g., electronic data capture, familiarity of 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   

This is your opportunity to tackle the world’s biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change. You have a voice, ideas and perspectives and we want to hear them. Because our success begins with you. Be part of something big. Be Bayer. 
 
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
 

 

 

Location:

Spain : Cataluña : Barcelona  

 

Division:

Enabling Functions 

 

Reference Code:

836047