clinical coordinator Remote
Phastar
Full Time
Remote
10.56 - 12.04 GBP Today
Job description
Overview:
Work as a senior data coordinator II on clinical and non-clinical trials; producing and validating eCRFs and databases to excellent quality whilst adhering to deliverable timelines. Producing, reviewing and updating eCRF specifications and sections of the Data Handling Manual. Leading clinical coding activities and management of third party data and eCRFs in order to produce a clean database. Acting as lead Data Manager on a suite of studies or more complex studies. Working closely with the Sponsor's study team and third party suppliers to meet project deliverables and timelines. Excellent team work ethos, able to manage workload of others, willingness to help others, share skills in a team environment and contribute to process improvement, company profile and business generation.
Responsibilities:Employees may be required to perform some or all of the following:
Qualifications:- Preparing stable draft eCRF specification for database build. Finalising eCRF specification and obtaining approval. Performing QC of eCRF specification
- 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. Approving release of database. Performing senior review summary of UAT findings for complex studies
- Specifying edit checks and performing senior review of the Data Review Conventions. Preparing edit check UAT scripts and performing UAT according to scripts. 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
- 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
- Preparing documents for third party data, performing senior review, QC and update of those documents. Establishing test and live data transfer processes through liaison with third party vendors. Liaising with third party vendors and / or client for resolution of process or contract 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
- Working as part of a study team to ensure allocated tasks are completed in a timely manner
- 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
- 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 Lead DM for larger suites of studies or studies of higher complexity ensuring quality and timely delivery of DM aspects of study. Liaising with Lead Programmer, Lead Statistician and Study Project Lead regarding resourcing and deliverables.
- Coordinating, facilitating and leading Kick Off meetings
- Implementing findings from lessons learned to ensure best practice on future studies
- Managing study database access authorisation, create, monitor and remove user access.
- Leading a team for furthering data management initiatives
- Leading a team to create articles, posters, presentations or publications. Critical review of articles, posters, abstracts, symposia, etc. with oversight for internal purposes
- Archiving study documentation following instructions in supplied SOPs. Ensuring completeness of DM section of study files throughout the progress of the studies. Archiving trial databases
- Leading DM teams for projects of significant complexity to ensure quality and timely deliveries on Phastar projects or client studies. Liaise with stakeholders to ensure successful project delivery
- Being point of contact for DM issues for the team. Highlighting / giving feedback to relevant line managers regarding any performance of team members.
- Managing own day-to-day workload to ensure all project goals are met and taking responsibility for study/ program level resources. Mentor junior team members
- Prioritising quality in everything that you do. Ensure the principles in the PHASTAR checklist are followed rigorously
- Helping network for potential recruits as and when required and representing the company at external events and conferences and presenting at conferences
- Reporting and potential new business opportunities to the business development manager
- Bringing changes to the attention of the company and being involved in updating processes. Proactively identifying own areas for development/ improvement and sharing knowledge through attending and presenting and the Phastar forums
- Helping others as and when required, proactively assisting less experienced team members on an ad-hoc basis and training and mentoring less experienced team members
- Attending, developing and delivering company-wide training (various aspects) as and when required. Maintaining training record to accurately reflect course attendance
- Ensuring clients (internal and external) remain engaged and well informed. Maintaining a positive client relationship
- Facilitating project team meetings to ensure teams are kept well informed at all times. Receiving and processing feedback from project teams
- Creating, reviewing and updating processes and SOPs. Taking responsibility for study compliance for processes and SOPs being followed
- Life Science degree, nursing qualification or equivalent experience
- Good awareness of clinical trial issues, design, and implementation.
- Familiarity with GCP and regulatory requirements
- Good experience of data management software systems and leading data processing activities within a regulated environment.
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.
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Phastar
phastar.com
London, United Kingdom
Andrew MacGarvey
Unknown / Non-Applicable
201 to 500 Employees
Company - Private
Biotech & Pharmaceuticals
2007
