- Trial Data Manager (TDM)
- Central Monitor (CM)
- Or developing expertise and capabilities under supervision as:
- Project Data Manager (PDM), as an associate PDM or supporting a local submission (e.g. in Japan or China)
- Risk Based Quality Management (RBQM) Business Partner (BP), e.g. as an associate RBQM BP or for a trial of low complexity
- In the role of a Trial Data Manager (TDM) for clinical trials led in-house or using business process outsourcing (BPO)
- Key liaison / Data Management lead to establish, align and confirm data management expectations for assigned trial(s), this requires regular interaction with other internal and external partners e.g. TCM, TSTAT, TPROG, TMCP, BPO partners.
- Responsible for CDM trial level oversight. Builds effective relationships with CROs/ vendor partners. Review protocols and identifies requirements for proper data capture including electronic Case Report Form design and processing of clinical data ensuring accuracy, consistency and completeness
- Oversee the design, creation and UAT Plan and testing of clinical study databases along with development of edit check specifications and manual data listings as required.
- Define or reviews creation and maintenance of all essential data management documentation including CRF specifications, eCRFs, annotated eCRF, eCRF completion guidelines, Data Management Plans (detailing complete data management processes throughout clinical studies), Data Transfer specifications and Data Review Guidelines, in accordance with the protocol, BI and project data standards.
- Integrates external data (non-CRF data) from vendors or other internal departments into the clinical trial database.
- Initiates and compiles Trial Master File (TMF) relevant documentation containing the necessary CDM / Biostatistics & Data Sciences (BDS) documentation for a trial together with other members of the trial team as appropriate. Therein ensures appropriate quality, scientific content, organization, clarity, accuracy, format, consistency and compliance with regulatory guidelines.
- Establishes conventions and quality expectations for clinical data and plans and tracks the content, format, completeness, quality and timing of the trial data collection process and other CDM deliverables via data analytics throughout the conduct of a trial.
- Throughout the trial, the function holder either performs or leads the respective trial level activities in the context of business process outsourcing (BPO) in CDM.
- Collaborates with the trial team to ensure that the database can be locked according to the planned timelines and quality. Responsible for the database lock and accountable for the integrity of the database.
- Ensures that SDTM (Study Data Tabulation Model) compliant data is available for analyses together with the Project Data Manager (PDM) and the SDTM programmer at the CRO (in the context of the BPO).
- Leads and facilitates the Medical and Quality Review (MQR) process and other trial team meetings. Presents and trains at trial team, CRA at investigator meetings.
- Ensures real-time inspection readiness of all CDM deliverables for a trial and participates in regulatory agency and BI internal audits as necessary.
- Identifies and communicates lessons learned and best practices at the trial level within CDM. Identifies and participates in DM related process, system, and tool improvement initiatives within CDM/BDS.
- In the role of a Trial Data Manager (TDM) for fully outsourced trials, supervises and instructs the CRO in performing the above TDM tasks and leads trial level oversight, including planned timelines and fulfillment of quality expectations.
- Sets expectations for and defines specifications for data transmission with the CRO. Integrates the data from the CRO into the BI clinical trial database. Ensures that SDTM compliant data is available for analyses together with the responsible Project Data Manager (PDM).
- In the role of a Central Monitor (CM) for clinical trials
- Executes and manages the Risk Based Quality Management (RBQM) processes as described in the monitoring framework, this requires regular interaction with other internal and external functions e.g. clinical monitors, CRAs/site monitors, data managers, biostatistics, site personnel.
- Conduct root cause analysis on the risk signals of aggregated site and trial data (pulled from various sources) using risk reports. Identifies and investigates potential risks and trends with subject protection and reliability of trial results and compliance with the investigational plan for impact on site/country/trial activities.
- Provides direction to site monitors for additional remote and on-site monitoring activities for risk sites, within the scope of the trial monitoring plan.
- Oversees potential issues and findings requiring further review and follow-up and ensures appropriate actions are taken by the trial team members to investigate, resolve and document potential risks identified, including adequate documentation of resolution.
- Provides a regular and efficient mechanism of trial communication for the trial team including documentation and leads oversight meetings.
- Ensures real-time inspection readiness of responsible RBQM deliverables for a trial and participates in regulatory agency and BI internal audits as necessary, in conjunction with the RBQM BP.
- Identifies and communicates lessons learned and best practices at the trial level and with other CMs. Identifies and participates in CM related process, system, and tool improvement initiatives within CDM/BDS. Performs user acceptance testing and supports the development and maintenance of RBQM tools.
- In the role of a Project Data Manager (PDM), the function holder performs (selected) PDM tasks under the supervision of an experienced PDM, e. g. as an associate PDM or for a project of low complexity where existing standards, material and documentation can be re-used and built upon.
- Accountabilities include the definition, leadership and oversight of data management processes and deliverables for clinical projects (with one project comprising multiple trials in a substance in one indication) such as establishing expectations for CRF-based/external dataset content and structure, definition of project standards (e.g. SDTM, CRF, specifications such as for MQR, data cleaning, data transmission), review and acceptance of project level database elements, programming and validation of the project database (PDB), preparation and creation of CDM deliverables for regulatory submission and support of safety updates.
- Alternatively, the function holder may be responsible for the specific CDM deliverables and support for a local regulatory submission (e.g. in Japan or China).
- In the role of a Risk Based Quality Management (RBQM) Business Partner (BP), the function holder performs (selected) RBQM BP tasks under the supervision of an experienced RBQM BP, e.g. as an associate RBQM BP or for a trial of low complexity.
- Takes a leadership role with the project / trial team to establish, align and confirm RBQM expectations for assigned trial(s). The function holder performs (selected) RBQM BP tasks in the definition, leadership and oversight of Risk Based Quality Management (RBQM) processes and deliverables for one or multiple clinical trials such as guiding the project and trial team through the process of identifying and assessing risks at the beginning of a trial, initiating and facilitating RBQM risk review and assessment meetings, facilitating the implementation of required RBQM documentation and tools, authoring the quality report and assisting with any risk related questions that arise.
- Bachelor’s degree or Master’s degree from an accredited institution (e.g. MBA, MSc) with major/focus in Life Sciences, Computer Science, Statistics, or similar preferred.
- Experience in clinical research including data management and/or clinical trial management required. Initial experience within the pharmaceutical industry, CROs or academic sites: >=3 years.
- No leadership experience required.
- Technical / Analysis / Medicine:
- Any of the following skills: data visualization/reporting, analytics; i.e. able to interpret integrated data displays and metrics, identify and communicate trends.
- Experiences with Electronic Data Capture (EDC) processes
- Knowledge in and experience with any of the following: Data review in JReview, Risk Management Tools, Statistical Analysis Software (SAS) programming
- Ability to adapt to new technologies.
- Critical thinker and able to discern risks. Must be precise and able to detect subtle inconsistencies in data / structures.
- Planning / Organization:
- Excellent organizational skills, problem solving abilities, negotiation skills, time management skills and initiative.
- Must be able to work independently as well as part of a team.
- Able to effectively manage multiple assignments and adapt flexibly to changing priorities.
- Able to produce robust timelines and action plans, regularly review and follow up on progress and take decisive action in terms of follow up activities with local and global trial/project teams. Ensures work is completed effectively.
- Strong communication skills with the ability to simply summarize complex information. Ability to use a wide range of communication techniques and media (written and verbal). Confident and persuasive communicator to ensure that the message is clear and well understood.
- Ability to work collaboratively on multi-disciplinary project teams and to pro-actively manage relationships with external vendors.
- Mindful of local, global, internal and external cultures to ensure that messages are received positively and effectively.
- Good written and oral communication skills in the English language.
- Ability to lead and facilitate meetings.
- Ability to develop and deliver (technical) training.
- Responsible for the clinical trial database and the data collected within a clinical trial and/or for the identification, detection and assessment of risks in a clinical trial.
- Knowledge and experience in and continuing education of clinical trial designs, data standards, clinical trial conduct and methodology (International Conference on Harmonization (ICH) regulations.
- Good Clinical Practice (GCP), major regulatory authorities and relevant directives/regulations) are required. Internal and external negotiation skills are required.
- Ensures all tasks are carried out in accordance with respective applicable BI Standard Operating Procedures (SOPs), BI and regulatory guidelines and BI working instructions.
- Ensures that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with BI values.
Must be legallyauthorized to work in the United States without restriction.
Must be willing totake a drug test and post-offer physical (if required)
Must be 18 years ofage or older
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At Boehringer Ingelheim we create value through innovationwith one clear goal: to improve the lives of patients. We develop breakthroughtherapies and innovative healthcare solutions in areas of unmet medical needfor both humans and animals. As a family owned company we focus on long termperformance. We are powered by 50.000 employees globally who nurture adiverse, collaborative and inclusive culture. Learning and development forall employees is key because your growth is our growth.
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Boehringer Ingelheim, including Boehringer IngelheimPharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim AnimalHealth USA Inc., Boehringer Ingelheim Animal Health Puerto Rico LLC andBoehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmativeaction employer committed to a culturally diverse workforce. All qualifiedapplicants will receive consideration for employment without regard to race;color; creed; religion; national origin; age; ancestry; citizenship status,marital, domestic partnership or civil union status; gender, gender identity orexpression; affectional or sexual orientation; pregnancy, childbirth or relatedmedical condition; physical or psychiatric disability; veteran or militarystatus; domestic violence victim status; genetic information (including therefusal to submit to genetic testing) or any other characteristic protected byapplicable federal, state or local law.