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Senior Data Manager I

Employer
PHASTAR
Location
United Kingdom
Salary
Competitive
Start date
9 Aug 2022
Closing date
8 Sep 2022

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Job Details

THE COMPANY

PHASTAR is a multiple award-winning, top 10, data focused CRO specialising in providing statistics, programming, data management and data science services. With offices across the UK, US, Germany, Kenya, Australia and Japan, PHASTAR is a global CRO that is continuing to grow. In 2019, PHASTAR won the prestigious Queen’s Award for Enterprise, following our impressive growth from a one-person operation to a global CRO within a decade.

Our unique approach to data analysis, “The PHASTAR Discipline”, has led us to build a reputation for outstanding quality. With this as our core focus, we are looking for talented individuals who share our passion for quality and statistical expertise to join our team.

 

THE ROLE

 

Due to global expansion of PHASTAR’s Data Operations group, we have a Senior Data Manager I position available. Working as the data management lead for multiple studies, you will provide oversight of all data management activities, ensuring the efficient collection and delivery of the highest quality data. You will advise and provide support on all aspects of clinical data capture and analysis, from CRF design through to database lock. As a senior team member, you will liaise closely with clients and external vendors, providing exceptional customer service and data management expertise.

 

Key Responsibilities:

 

  • Review draft protocols and CRFs/eCRFs for potential data collection, database structure or data entry problems and provide feedback to the project team Design/review eCRF layout ensuring consistency with protocol requirements Create/test the study database according to the eCRF specifications Design/review/program/test edit checks Assist/lead coding of medical terms Data management lead for studies; providing guidance for other data managers on the team, co-ordinating data processing activities, ensuring clinical databases are correct, delivered on time and budget and are of excellent quality Implement CDASH standards, produce and review CRF specifications following the CDASH implementation guide Work in a team for furthering data capture systems development Attend project teleconferences and ensure assigned actions are completed within the required timeframe Actively participate (including presentations) at project Kick Off meetings and Clinical Trial Team meetings for the assigned trials ensuring appropriate level of support, communication provided Responsibility for study level resources Timely issue escalation Liaise with Study Statistician and Study Project Manager regarding resourcing, timelines and deliverables Be point of contact for data management issues for the team Responsibility across multiple studies Provide support for Data Safety Monitoring Board and all other vendors including training of Investigators, site staff and the client’s internal teams Work in a cross-functional team environment in experience appropriate studies; identifying issues, giving solutions and advice on cross-functional issues throughout study conduct Ensure effective communication between functional teams and with the client, providing a high level of client satisfaction through successful execution of projects Report any potential new business opportunities to the business development manager Ensure audit readiness and involvement in the CAPA process Manage day-to-day workload to ensure project deliverables are met Prioritise quality in all activities undertaken, by ensuring the principles in the PHASTAR checklist are followed rigorously, and carefully performing self QC of own work Implement Good Clinical Practice and adhere to regulatory requirements at all times

Skills and Experience Required:

 

  • Life Science degree, Nursing qualification or equivalent experience Experience within the pharmaceutical industry to have a good awareness of clinical trial issues, design, and implementation Experience of data management software systems especially Medidata RaveMedrio Knowledge of coding dictionaries including MedDRA and WHODrug Familiarity  Excellent written and verbal English Excellent teamwork, with willingness to help others, ability to problem solve and seeing others point of view Enthusiastic and positive outlook Calm and professional under all circumstances Implement approaches that will result in error-free results Flexible and adaptable in outlook Open to feedback with a view of continual improvement Technical expertise, i.e. knowledgeable on CDASH approach and SDTM Ability to work competently and independently in cross-functional teams Proactive in identifying and resolving data processing issues throughout study conduct and feedback to relevant team members Project management skills to ensure projects are managed and monitored so that client deadlines and deliverables are met and in accordance with SOPs and budget

WHY PHASTAR

 

 

 

This is a unique opportunity to join a company where hard work and fun coincide! We offer structured training and development plans, the opportunity to continue your own research, a competitive salary, an excellent benefits package and flexible working arrangements, all within a relaxed and friendly working environment where fun is encouraged and renowned social events are organised throughout the year.

 

 

 

***PHASTAR does not accept any CVs received from recruitment agencies. In the event that speculative CVs are submitted by recruitment agencies, PHASTAR reserves the right to contact these candidates directly and consider them for current/future vacancies without any financial obligation to the recruitment agency in question. This applies to any CVs sent directly to any PHASTAR employee.***

 

 

Company

PHASTAR is a specialist biometrics contract research organization offering statistical consulting, clinical trial reporting, data management and data science services by providing expert consultants and managing and delivering in-house projects, FSP-style arrangements and preferred partnerships. Our number one priority is ensuring on time, quality work: every project undertaken is supervised on methodology and utilizes internal processes designed to guarantee optimal quality, inspired by 4,000 years accumulated technical experience across the company. PHASTAR is headquartered in London (UK) and North Carolina (US) and has 14 offices worldwide

Company info
Location
Unit 2,
2A Bollo Lane
London
W4 5LE
GB

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