Standards Implementation Lead (Clinical Data Standards)

Standards Implementation Lead (Clinical Data Standards)

Location: High Wycombe, UK; Bangalore/Hyderabad, India

At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and sophisticated diseases of our time.

J&J Innovative Medicine -Research & Development discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.

We have an exciting opportunity for a Standards Implementation Lead(SIL) to be responsible for ensuring that standards policies and principles are followed at trial level as determined by Data Standards Governance.

The SIL takes a leadership role in influencing, directing, and monitoring optimal end-to-end Standards Implementation and governance throughout the entire lifecycle of a clinical trial. The job holder acts as a liaison between the Cross Functional Trial Team, the Clinical Data Standards organization and Governance committees.

The SIL acts as both standards' advisor, who collaborates and supports the standards usage and implementation, and as standards monitor, who understands and drives the correct and optimal implementation of standards at trial level. You will have a key role in the governance process, reporting improvement needs to the standards organisation, and providing guidance and training in the implementation of standards to trial teams.

Principal Responsibilities:

a. Leads Standards kick-off meeting at trial initiation and in Data Plan Meeting or any other trial meeting where standards input is relevant.

b. Maintains expert understanding and familiarity with standards libraries from protocol, collection to delivery and analysis standards.

c. Maintains knowledge of industry standards to assigned disease area.

2. Responsible for providing standards guidance and support to the trial team.

a. Advises on end-to-end and specific stage of standards.

b. Supports decision on implementation of standards.

c. Oversight of TA/DA standards elements across portfolio and upcoming trials

d. Supports the design and development of new trial specific elements for their compliance with standards principles.

3. Facilitates impact assessment of study level changes to a standard, and ensures the study team maintains full documentation for utilisation in downstream processes and tools (Data visualisations, SSRs, Analysis outputs, etc.)

4. Key stakeholder in the change request process and in Governance committees.

a. Acts as the first stage gate for raising change request.

b. Coordinates the follow-up of Change Requests from generation to implementation at trial level and follows-up on promotion to the standards.

c. Supports the assessment and promotion of lower-level forms / analysis standards to higher level standards.

d. Attend Governance councils’ meetings as appropriate.

e. Proposes optimisation of new / existing standards based on Trial input.

f. Provides key insights and trends into Standards Governance body for change control and continued development.

5. Responsible for ensuring standards compliance and standards metrics are run at key timepoints during the trial.

a. Collaborates with relevant function on running compliance reports.

b. Ensures compliance with standards principles for design and development of new trial specific elements.

c. Proactively monitors Standards Implementation within and between trials in Portfolio/DA/TA, to help early identification of issues and ensure consistency.

Principal Relationships:

• Within Clinical Data Standards: Data Collection Standards, Data Delivery Standards, Data Analysis Standards, Submissions and Regulatory Intelligence, Data Standards Planning. Outside Clinical Data Standards: CFTT, Clinical Programmers, Statistical Programmers, IDAR niche experts (trial set up and integration), IDAR technical and disease experts, IDAR Global Data Managers, IDAR Data Acquisition Experts, Statisticians, Therapeutic Area Scientists (Biomarker/Translational), Therapeutic Area Clinicians, Clinical Project Scientists, EBIS (e.g. integrations, ePRO).

Qualifications

Education and Experience Requirements:

• Bachelor’s degree in computer science, life science or another relevant scientific field is required!
• Minimum of 10+ years of clinical trials experience with end-to-end process knowledge from protocol through data collection and data analysis.
• Minimum of 5+ years in Clinical Data processing or Clinical Data Standards is required.
• Deep expertise in CDISC standards (SDTM and/or ADaM) is required.
• Demonstrated project management experience is required.
• Experience with rapid prototyping or similar methodologies is preferred.
• Experience of working in cross-industry initiatives is a plus.
• Leadership experience working in a cross-functional team environment with strong collaboration, facilitation, and problem-solving skills is required. Must be able to manage diverse viewpoints and drive issues to resolution.
• Excellent oral and written communication skills are needed.
• Ability to build robust relationships and strong negotiation skills are required.

Other relevant skills and experiences and skills taken into consideration.

• Experience with Clinical Data Management / Statistical Programming
• Experience with SAS based systems.
• Experience with CDISC standards (SDTM, CDASH, ADaM, define.xml, etc.)
• Experience in prioritizing and managing multiple tasks simultaneously.
• Outstanding written and verbal communication skills in English

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Are you ready to join a dynamic and inclusive team? Apply now!

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.