Principal Clinical Data Manager

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Role Overview

Phastar is a leading global biometric Contract Research Organization (CRO) that partners with pharmaceutical, biotechnology and medical device organizations to provide expertise and processes to manage and deliver on time, quality biostatistics, programming, data management and data science services. With offices across the UK, US, Germany, Denmark, Kenya, Australia, India, China and Japan, Phastar is the second largest specialized biometic provider globally, and the largest in the UK.

Responsibilities

• Preparing stable draft eCRF specification for database build, finalising eCRF specification and obtaining approvals.
• Performing QC of eCRF specification and creating project level or therapeutic area level standards.
• Preparing eCRF UAT scripts and performing UAT according to scripts; creating standard CDASH eCRFs from a library.
• Creating study specific / complex eCRFs, checking protocol requirements are met and approving release of database.
• Performing senior review summary of UAT findings for complex studies.
• Specifying edit checks, performing senior review of the Data Review Conventions, preparing edit check UAT scripts and programming study specific / complex edit checks.
• Producing and reviewing data listings for data anomalies and performing sight review of eCRF data.
• Reviewing edit check outputs and actioning as appropriate; actioning data query responses; raising manual data queries within the study database; resolving issues arising with data queries.
• Reviewing and entering normal ranges for local laboratory data, managing annual updates and raising issues with sites on local laboratory data.
• Defining and generating key study metric reports for periodic review by client, including QC; overseeing progress of data entry by sites, monitoring by CRAs and responses to data queries.
• Producing key study metric reports and KRIs for RBM approach; reporting monitoring and mitigating actions in the issues tracker.
• Preparing, performing senior review / QC and updating documents for the data handling manual; performing senior review of data handling manual and giving advice for complex study procedures; compiling all documents in the DHM and obtaining client approval.
• Assigning dictionary codes to medical terms, performing QC of coded terms and reviewing coded data listings for consistency; liaising with study Medical Physician to resolve coding issues.
• Reviewing reconciliation outputs and resolving data issues with client and / or third party vendors.
• Performing senior review of the client’s safety management plan; reviewing safety data reconciliation outputs and resolving data issues.
• Acting as the independent data manager for non-assigned studies and performing QC as specified in the study-specific QC plan; inputting into the Database Lock Checklist and locking eCRFs.
• Preparing, performing QC and updating the database lock QC Plan; obtaining client approval of the QC plan.
• Performing senior review of QC findings; preparing and finalising the Database Lock Checklist, coordinating Investigator eCRF sign off and exporting locked data.
• Leading DM section of Blind Data Review meeting, ensuring data related issues are explained and actions / findings addressed.
• Managing eCRF locking and unlocking and other lock related administration of study databases.
• Exporting casebook PDFs and cataloguing for return to site; ensuring sites have received and can access their study casebooks prior to database archiving.
• Working as part of a study team to produce quality data.
• Taking responsibility for data management deliverables within reporting teams for complex studies and working independently as a data management study lead on behalf of other companies.
• Acting as the study project lead / manager ensuring projects are managed and monitored so that client deadlines and deliverables are met; liaising with Lead Programmer, Lead Statistician and Study Project Lead regarding resourcing and deliverables.

Qualifications

• Experience within the pharmaceutical industry to have a good awareness of clinical trial issues, design and implementation, GCP and regulatory requirements.
• Good experience of data management software systems and coding dictionaries including MedDRA and WHODrug.
• Extensive experience of leading data processing activities within a regulated environment.
• Experience with project management or resource management and working with budgets.

Apply Now

Should you feel that you have the right skill set and motivations for this position, please apply! With the world’s eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer flexible working, part-time hours, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package.

Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all.