Band 4 Senior Cancer Research Data Manager

Job overview

A fantastic opportunity has just become available at band 4 level for a senior cancer research data manager to join a busy and successful Oncology/Hematology Research delivery team here at UHBFT, HGS. The Cancer research portfolio is one of the largest in the region and has an exciting range of commercial and academic clinical trials. The trials include observational, complex interventional and translational studies.

As a senior cancer research data manager you will be responsible for providing administrative support on cancer clinical trials, you will work closely with the research team to ensure that data is reported as per GCP standards. You will make sure documentation is regularly updated and will liaise with clinical trial centers and pharmaceutical companies to ensure the smooth running of cancer research. You will be expected to adhere to appropriate regulations, principles and good clinical practice that ensure high quality research and protect patients.

Main duties, tasks & skills required

To be successful in this role you will need to be educated to a degree level OR have 12 months clinical research experience as well as GCSE grade c or above in English language or maths.

Main duties & responsibilities (PLEASE SEE JOB DESCRPTION AND PERSON SPECIFICATION FOR FULL JOB DETAILS):

• Participation in pharmaceutical and academic clinical trial work carried out within the department.
• To maintain and update the Investigator Site File for each study.
• To submit study amendments to R&D for approval and to ensure documentation is updated accordingly.
• To maintain and keep up to date the Trial Delegation of Duties Log.
• To maintain study specific patient screening logs.
• To liaise and meet with Trial Monitors and Study Coordinators from external Companies/trial centres.
• Joint responsibility for completion of CRF’s to International Good Clinical Practice Standards.
• To use different systems to upload data as well as internal databases, such as EDGE.
• To answer queries generated by Trial Centres on the CRF data.
• To report Serious Adverse Events within the 24 hour reporting time period set by Good Clinical Practice.
• To ensure trial specific patient trackers and databases are kept up to date.
• To assist with the close out visits and archiving of Trial material.
• General administrative duties.

In return, we can offer you continued professional development and the opportunity to be part of a dynamic and high quality cancer research team.

About us

We are recognised as one of the leading NHS Foundation Trusts in the UK. Our vision is to Build Healthier Lives, and we recognise that we need incredible staff to do this.

Our commitment to our staff is to create the best place for them to work, and we are dedicated to:

Investing in the health and wellbeing of our staff, including a commitment of offering flexible working where we can;
Offer our staff a wide variety of training and development opportunities, to support their personal and career development objectives.

UHB is committed to ensuring that our staff are treated fairly and feel that they belong, by creating a kind and inclusive environment. This is about equity of opportunity; removing all barriers, including discrimination and ensuring each individual member of staff reach their true potential, achieve their ambitions and thrive in their work. This is more than words. We are taking action. Our commitment to an inclusive culture is embedded at all levels of the organisation where every voice is heard, driven by our diverse and active staff networks, and at Board level by the Fairness Taskforce led by our CEO. We nurture a culture which empowers staff to challenge discriminatory behaviours and to enable people to bring their ’whole self’ to a kinder, more connected and bold place to work.

Job description

*Please Note : For a detailed job description for this vacancy, please see attached Job Description*

Person specification

Qualifications

Essential

• Educated to Degree level

Or

• 12 months Clinical Research experience
• GSCE grade C or above in English Language or Maths

Experience

Essential

• Working to deadlines under own initiative (E)
• Working within a team environment (E)
• Able to interpret and analyse data (E)

Desirable

• Working in clinical research for at least 12 months (D)
• Awareness of Clinical Trial procedures and methodology (D)
• Has understanding of the principles of safeguarding and mental capacity (D)
• Has knowledge of Good Clinical Practice (D)

Additional Criteria

Essential

• Ability to communicate with all levels of staff. (E)
• Ability to work with a range of IT applications including PowerPoint/ EXCEL and WORD. (E)
• Excellent keyboard skills (E)
• Good Team worker (E)
• Commitment to delivering the "Best in Care" and uphold Trust Visions and Values (E)
• Positive and enthusiastic attitude (E)
• Ability to communicate articulately (E)
• Friendly and approachable (E)
• May be called upon to work at other sites across the Trust (E)

Desirable

• Experience of using Electronic Case Report Forms - Eg RAVE, INFORM, ORACLE. (D)

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.