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.
Principal Clinical Data Manager
The Principal Clinical Data Manager leads the execution of data management activities necessary for the generation of hypothesis and for decision making in research or development phases, and for the
preparation of submission data, and required documentation, for regulatory authorities and the greater clinical research community.
Key tasks and 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.
Qualification & Competencies:
The incumbent possesses 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, desires to improve best practices, and is respected as a reliable partner in Clinical Project Teams and Study Teams.
• 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.
• 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.
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.
Reward is important to us, employees benefit from excellent employment conditions, such as:
- competitive salary and performance bonus
- 25 days annual leave plus bank holidays
- Private Healthcare, generous pension scheme and Life Insurance
- Employee discount scheme
- State of the art offices (award winner for British Council for Offices, Best Fit Out Category 2018)
- International career possibilities
- Flexible working
Are you up for the challenge? If so, please apply below.
Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve people’s lives? Then send us your online application including cover letter, CV and references.
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.
Reference Code: 339145
Functional Area: Clinical Development & Operations