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Clinical Data Team Lead

3 months ago

Cambridge, Cambridgeshire, United Kingdom ThermoFisher Full time

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Are you a data and a people person?

Are you keen on working with the CDM Project Manager to lead, create and monitor clinical trials?

Here's your team. We manage and clean the data collected in a clinical trial — from the design and build of the database and edit checks, through the entry and cleaning of data to the final delivery of clinical trial data. We work closely with the project teams and clients to identify standard methodologies and processes, meet and exceed our clients' needs, and do the right thing to earn their trust.

As a (Senior) CDTL, you will act as a lead data manager for one or more projects and a liaison to the PM and /or client as required.

Here's what the role includes:
  • Applies relevant components of the project protocol to daily tasks and directs others on how to apply to their daily tasks.
  • Acts as an interdepartmental and client liaison for all DM study activities.
  • Produces project-specific status reports for management, PM and/or clients on a regular basis.
  • Monitors and analyzes study metrics and escalates per the organization's risk management processes.
  • Participates in business development activities by assisting with bid preparation and representing data management at bid defense meetings, where required.
  • Assists with project forecasting of hours and identification of resource requirements.
  • Assists with the oversight of project budgets including identification of potential out of scope work and participation in the Contract Modification process.
  • Independently leads and delegates tasks to ensure timely completion of project activities to project timelines, quality and budget.
  • Mentors junior level staff on all associated tasks within a study.
  • Assists with administrative and financial oversight for allocated projects.
If you're interested, here's what we're ideally looking for:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

2+ years of previous experience in a leading data management role

Knowledge, Skills & Abilities:
  • Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectations
  • Ability to use interactive computer programs
  • Good written/ verbal communication skills with a strong command of English language and grammar; good organizational, analytical/problem solving skills and attention to detail
  • Ability to work productively in both a team environment and independently as needed
  • Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
  • Strong customer focus and excellent social skills.
  • Ability to advise and train study team
  • Ability to act as a study or department guide for DM processes
  • Ability to support project resourcing and project timeline planning and adherence to timelines

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel. On top of the salary, we offer 5000 EUR joining bonus

At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

Our 4i Values:

Integrity – Innovation – Intensity – Involvement

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application – we'd love to hear from you.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.