Principal Clinical Data Manager

Bayer

Jan 9

Applications are closed

Job
Full-time
Senior & Expert Level
Research & Development
Healthcare
Barcelona

Requirements

Bachelor’s degree (or equivalent/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, Drives Results, Manages Complexity, Plans & Aligns. Other key capabilities like Collaborates and Instills Trust should be also displayed by the incumbent.
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.

Responsibilities

Assumes ownership and leadership for all Clinical Data Management owned deliverables within assigned compound, projects and studies and provides leadership to respective CDM staff, interfacing functions and teams in order to support and achieve defined business goals.
Serves as the key subject matter expert on topics related to data management activities including specific activities and processes in early clinical development phases. Contributions 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 initiatives), presenting best practices at internal and external industry meetings meetings/congresses, and participating in due diligence assessments.
Governs use of key data management elements across studies in assigned projects: assumes ownership of development and maintenance Medical Standards relevant to the area of responsibility; contributes to data structure standards; review results of applied Important Medical Event (IME) List, medical coding conventions.
Accountable or a contributor for CDM deliverables on study and/or project level.
Ensures adequate application of Data Management Best Practices across studies within assigned projects: review Study Team documents for project consistency; ensure the adequate documentation of all data management activities according to SOPs.
Provides 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.
Advises on resource planning/allocation based on forecasted activities per the Clinical Development Plan (CDP) and actual study/project metrics.
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).
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.
Ensures smooth phase-transitioning of projects between research and development phases in P&O, is instrumental to facilitate data access and exchange between research and development functions.
Organizes 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. Establishes data management best practices for data generated in relevant research activities.
Actively supports assessment of future trends 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.
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 Team.
Supports the development and implementation of DMAR and/or OSBU DM strategic initiatives and activities.
Contributes to projects and initiatives aimed at improving and optimizing the delivery of DMAR. DS&A, Portfolio & Operations, OSBU.
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.
Represents CDM as the Core Study Team and/or Core Project Team member for internal and outsourced studies, and coordinates the Project and Study DM Team in any aspect.
Tracks and leads project-level clinical data management activities: manage PDM Teams/Early PDM Teams efficiently; ensures the timely delivery of high-quality study databases and smooth operation of SDM teams; identifies issues, defines and directs resolution measures; reports progress and escalate issues into management.
Manages cross-functional team memberships and interfaces effectively: closely aligns activities with Statistics function applying the 2-Lead model principles, serves as GCDM member of the core Clinical Project 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; manages conflicts constructively; provides timely and relevant feedback.

FAQs

What is the primary role of a Principal Clinical Data Manager at Bayer?

The Principal Clinical Data Manager leads the execution of data management activities necessary for generating hypotheses and making decisions in research or development phases, as well as for preparing submission data for regulatory authorities.

What qualifications are required for this position?

Candidates must possess a Bachelor’s degree (or equivalent/higher) in Natural Sciences, Life Sciences, Informatics, Medical Documentation or related subjects, along with at least 7 years of experience in data management, including 2 years as a responsible DM lead on studies/projects.

What experience is necessary for this role?

At least 7 years of study and/or project-level experience in data management, with at least 2 years demonstrating full responsibility as the DM lead on studies or projects is required.

Will I be required to manage a team as a Principal Clinical Data Manager?

Yes, the Principal Clinical Data Manager will lead a Study Data Manager (SDM) team and coordinate with various extended Study Team members to ensure timely and quality data management deliverables.

What are the core competencies needed for this position?

Essential competencies include Customer Focus, Drives Results, Manages Complexity, and Plans & Aligns, along with the ability to collaborate and instill trust in a global environment.

What is the work location for this position?

The position is located in Barcelona, Catalonia, Spain.

How does the Principal Clinical Data Manager contribute to compliance?

The Principal Clinical Data Manager ensures compliance by performing duties in accordance with SOPs, GCP, ICH guidelines, and maintaining thorough documentation for all projects/studies.

Is there a focus on mentoring or training junior staff?

Yes, the Principal Clinical Data Manager is involved in mentoring junior staff and training team members in data management best practices.

What is the significance of data management in clinical trials at Bayer?

High-quality data management is crucial as it directly impacts the company's ability to make informed decisions regarding the continuation of development programs and the safety and marketability of its portfolio assets.

What methodologies and technologies should candidates be familiar with?

Significant experience with data management methodologies and technologies, such as electronic data capture and data warehousing, is preferred.

Are there opportunities for growth and development within this role?

Yes, the position offers prospects for a varied and meaningful career, allowing individuals to expand their skills and contribute to important projects in clinical research and data management.

Bayer

Science for a better life

Science & Healthcare

Industry

10,001+

Employees

1863

Founded Year

Mission & Purpose

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Our products and services are designed to benefit people and improve their quality of life. At the same time, we aim to create value through innovation, growth and high earning power. Our products help address some of today’s biggest challenges, including global population growth, an aging society and the need to make efficient – and, wherever possible, sustainable – use of natural resources. In line with our mission “Bayer: Science For A Better Life,” we aim to improve people’s quality of life by preventing, alleviating or curing diseases. We also help provide an adequate supply of high-quality food, feed and renewable plant-based raw materials. For these endeavors, we focus on developing and successfully commercializing innovative products and solutions based on scientific knowledge.