PRINCIPAL CLINICAL DATA MANAGER

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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.
Principal Clinical Data Manager     Position Purpose.
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.
The Principal Clinical Data Manager is proficient in at least one area related to clinical data management, such that s/he may be considered a subject matter expert on the respective topic.
The Principal Clinical Data Manager may assume the business role of a Study Data Manager (SDM) in several clinical studies.
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 includes the co-accountability with the Statistics Lead to create, maintain and manage the Project Plan.
The Principal Clinical Data Manager may also support research-driven activities, or support the handling of data provided by highly specialized functions (e.
., Pharmacokinetic data, Biomarker data) ensuring data management best practices, and the usability of the generated data in regulatory processes.
The Principal Clinical Data Manager may also assume the role of a Project Data Manager (PDM) or Early Project Data Manager (EPDM).
In this role, the Principal Clinical Data Manager is a key driver of medical standards implementation and maintenance at the project level as well as ensuring a consistent standards handling in the project’s studies.
This critical responsibility is necessary to ensure the project data is aligned with the Clinical Development Plan.
The PDM/EPDM ensures consistency across studies through close interaction with the Clinical Project Team or Early Clinical Team, mentoring/coaching of SDM(s) and overseeing the Project Data Management team.
The Principal Clinical Data Manager supports proactive DM specific project planning and tracking of assigned projects from D3 to PoC or to submission.
  Scope.
Global   Major tasks and responsabilities.
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.
  DM Expertise   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.
., QSD initiatives), presenting best practices at internal and external industry meetings meetings/congresses, and participating in due diligence assessments.
  PDM/EPDM tasks   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.
.
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.
  Implementing Strategy   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.
  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.
  Added value for the company.
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 Principal Clinical Data Manager is responsible for the consistency in support, planning and delivery of data management deliverables in several assigned complex studies, projects, 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, and includes the crucial phase of translational medicine.
  Work Interactions.
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.
  Qualifiactions & Experience.
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.
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.
., electronic data capture, familiar with data warehousing).
  Demonstrated understanding of regulations and guidelines (e.
.
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.