Associate, Data Solutions, Clinical Pharmacology - United Kingdom
Want to know company name or location? Company managed [?]
- Across the globe, our company employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteers
- We are passionate about building on this precedent in our continued pursuit to make life better for individuals, communities, and the world around us.
- Our heritage and our values are the foundation of our promise to unite caring with discovery to make life better for people around the world.
We make medicines that help people live longer, healthier, more active lives.
Integrity, excellence, respect for people
We will make a significant contribution to humanity by improving global health in the 21st century.
Technical Leadership (50%)
- Consults to ensure that data acquisition, database design, and observed dataset requirements are reflective of specific protocol objectives
- Provides direction and expertise to study teams to secure adherence to company standards
- Provides input to ensure controls are in place to secure data integrity and patient privacy is maintained
- Proactively anticipates and prevents technical problems from impacting final data deliverables, mentors others on technical problem prevention and resolution
- Supports project teams on achieving client satisfaction through delivery of quality data, on-time and on-budget
- Proactively provides technical guidance to study teams regarding data system processes and requirements
- Provides expert review and guidance in the development of CRF/eCRF design specifications, database design specifications, validation specifications and report design.
- Ensures consistency of data collection across studies and programs, applying both company standards and industry initiatives (e.g. CDISC) as necessary
- Helps create scope scenarios and negotiates outcomes with study teams while taking into account the cost and value of scenarios
- Utilizes therapeutic knowledge and possess a deep understanding of the technology used to review data to ensure database deliverables are consistent and accurate
- Effectively applies knowledge of internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to data deliverables
Submission Activities (25%)
- Coordinates delivery of submission package relative to data management deliverables (i.e., aCRFs, DDD, datasets, notable CRFs) for clinical pharmacology including timeline management and location/conversion of legacy trial data.Consults with biopharm coordinator for contracting submission activities with vendor
- Maintains suite of tools for document creation/review of submission deliverables
- Provides ongoing solutions for publishing requirements
- Maintains current knowledge of industry and regulatory standard requirements for submission activities, frequently liaisons with key cross functional partners
- Partners with team members for regulatory responses
- Facilitates the availability of data for submission activities
Vendor Relationship (10%)
- Establish and define quality assurance oversight plans and metrics associated with outsourced services
- Ensures vendor performance for the program level i.e., flow of data, including across niche vendors and niche data sources
- Works with internal partners to increase vendor/sponsor efficiencies and support collaborative relationships
Process Improvement (10%)
- Continually seeks and implements means of improving processes to reduce cycle time and decrease work effort
- Actively participates in shared learning within and outside of Clinical Pharmacology
- Works with partners to increase vendor/partner efficiencies
- Interfaces with customers on solutions, requirements, continuous improvement
- Collaborates with peers to establish global data management competency models and assist with the development of training programs and ensure staff achievement of role competencies
Asset Protection (5%)
- Understands the confidential nature of company information and takes necessary steps to ensure its protection.
- This includes understanding various aspects of Privacy as it relates to the data managed within function.
- Ensures that an appropriate confidentiality agreement has been executed before disclosing confidential company information to CROs or other outside parties
- Accepts obligation to company for compliance to the integrity of the company
Education and Experience
Bachelor’s degree or equivalent experience
- Minimum of 3 years’ experience in clinical data management and/or 5 years’ experience in drug development in areas intersecting with clinical data management (e.g., clinical operations,statistics, information technology, health outcomes, etc.),Ability to work in ambiguous situations within the team to identify and resolve complex problems
- Demonstrated extensive in-depth knowledge of data management processes and principles in the specialty and the ability to articulate: Data flow, structure and format of data, CRF Design, Clinical Data Base Development, Randomization, Data Acquisition, Data Movement, EDC, CRF Processing, Submission Assembly and Validation Procedures
- Clinical knowledge and an ability to liaise effectively with study team members (i.e. Data Sciences, Statistics, PK, Operations, Medical)Demonstrated ability to understand customer perspective and deliver solutions that meet expectations
- Ability to work cooperatively with key internal and external stakeholders to ensure success
- Strong SDTM and therapeutic/scientific knowledge
- Vendor mgmt, Project mgmt, and virtual team environment experience
- SCDM certification
- Strong interpersonal and leadership skills
- Excellent oral and written communication skills
- Familiarity with clinical data tools and technologies
- Technical knowledge to develop requirements and/or study/project deliverables (i.e. SAS,Oracle)Experience in forms design and layout
- Understanding and experience in using data standards
- Knowledge of medical terminology
- Process management expertise