Data Collection Standards Expert Pharmacokinetic Specialist
The Data Collection Standards Expert (DCSE) within IDAR Standards organization co-owns and co-leads the Data Lifecycle Plan (DLP) development which documents standard data collection and analysis strategy and content for defined compound development programs. The DCSE is also responsible for defining transfer metadata, controlled terminology and mapping to SDTM in support of ongoing trials and in relation to complex data types. The DCSE is expected to have or develop a working knowledge of data collection systems and tools including electronic case report forms (eCRF's) and data transfer agreements (DTA's). The DCSE is also expected to have sufficient understanding of all clinical data types in order to support the development of the DLP, whilst also possessing and further developing specific expertise in the standards and science pertaining to specific data streams especially pharmacokinetic and pharmacodynamic data. The DCSE is expected to have sufficient understanding of CDISC SDTM standards and Janssen's implementation of those standards to ensure that requirements driven by operational and scientific needs defined in the standards can be applied in a compliant and consistent manner within the standards framework to meet the needs of regulatory submission. The DCSE is expected to collaborate with other standards teams, R&D functions and subject matter experts to ensure that collection standards are compliant, fit for purpose, implementable, consistent, future proof and maintained.
The DCSE will drive the development of clear specifications of the data collection requirements and work with the Integrated Standards and Analytics team to ensure that the data collection standards are built in alignment with these specifications and are fit for purpose. This includes, but is not limited to, ensuring compliant domain assignment, definition of new variables and controlled terminology to support the data being collected
The DCSE will facilitate adoption of standards developed for any given compound development program. The DCSE will be support Standards Governance. The DCSE may be consulted at any time throughout the compound development process for advice and guidance on data collection standards implementation.
The DCSE is expected to
- Co-owns and co-leads the development of the Data Lifecycle Plan.
- Develops clear specifications for data collection standards and partners with the Integrated Standards and Analytics team to ensure that these standards are accurately built and are fit for purpose.
- Facilitates adoption of developed standards.
- Provides advice and consultancy to clinical teams and data managers on trials using data collection standards.
- Ensures that source data, e.g., eCRF or non-eCRF electronic data be that raw or (Data Transfer Agreement (DTA) driven, can be mapped to target datasets, e.g, Data Review Model (DRM), SDTM in an unambiguous and regulatory compliant manner.
- Partners with other DCSE's to ensure a sharing of knowledge and consistency in approach across collection standards development and implementation
- Develop and perform data collection standards specific training in content, documentation requirements, process and terminology, to both internal and external key stakeholders
- Collaborates with business and technology leaders in developing platforms and tools to enable real time data availability and manage standards metadata.
- Leading or becoming a key stakeholder in Subject Matter Expert (SME) teams and/or Communities of Practice team related to the data type/streams, tools or processes of expertise especially Pharmacological data.
- Manage Pharmokinetic process guidance and documentation. Key collaborater with Janssen departments: bioanalysis laboratories, global clinical pharmacology, statistical programming and external PK laboratories
- Ensures the development and maintenance of terminology employed in data collection including scientific research as needed. Ensures alignment with published CDISC controlled terminology and other terminology standards as appropriate.
- Partners with other IDAR groups dealing with specialist vendors in relation to new vendor selection, participating is lesson learned meeting and leveraging best practices, and ensuring alignment in approaches related to data collection.
- Provides support for legacy systems and standards as needed.
Responsibility for Others:
This position reports to the Head of Data Collection Standards and has no direct reports. This position executes work according to the portfolio prioritization of standards development and as required through support of legacy standard needs. Status of work is self-managed and is discussed with the Head of Data Collection Standards at major milestones and deliverables.
Participates in (Global Clinical Development Organization (GCDO) and Research and Development Organization (RDO) initiatives as assigned
Participates in people development opportunities through coaching and mentoring
Functional contacts within IDAR include, but are not limited to Head of Data Collection Standards, representative from other Standards pillars as needed, IDAR Liaison, Data Management Therapeutic Area Experts, Global Data Managers (GDM), Data Delivery and Analysis Leads, Risk Management Central Monitoring Leads, Value Stream Leads.
Functional contacts within the organization (as collaborator or peer) include, but are not limited to GCDO Global Program Leads, GCDO Global Trial Leads, Clinical Teams - as needed, Janssen Research Procurement, External Alliances and Project Coordinators. Due to the pharmacokinetic data expertise, there will be a strong collaboration with Global Clinical Pharmacology and Janssen Biologics functions
Contacts outside the organization include but are not limited to, external vendors (both ancillary data vendors and data management vendors) and industry standards organizations as applicable.
Education and Experience
Bachelor degree and 6+ years of relevant experience OR Master degree and 4+ years of relevant experience OR PhD with post doc experience and 3+ years of experience OR equivalent through experience alone. University/College degree in a scientific discipline is preferred.
A working knowledge of data management practices (including tools and processes) as well as a comprehensive understanding of SDTM and controlled terminology standards is required. An broad understanding of scientific clinical data as well as an expertise in Pharmacokinetic / Pharmacodynamic data in required. A willingness to develop expertise in other complex data is required. Project management experience, dealing with customers, leading teams to successful outcomes, negotiation and leading through influence are required. Experience with working in cross functional teams is required.
Qualities and Characteristics
Demonstrated strong communication skills and experience working within a matrix environment. Excellent leadership, decision-making skills and proven ability to foster team productivity and cohesiveness, act as a change agent, and adapt to rapidly changing organization and business environment. Demonstrated innovative thinking to allow for optimal design and execution of data mapping and transfer strategies.
In depth knowledge of regulatory guidance documents such as GCP / ICH requirements and relevant clinical R&D concepts.
Other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility.
North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Janssen Pharmaceutica N.V. (7555)
Clinical Data Management
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