BRC & Early Phase Manager

Job description

Job responsibilities

Research Project Management

Working closely with the Clinical Director of the ECMC/CRF and the CCC BRC Lead on all CCC activities relating to the national funding bids.

Working closely with the Principal/Chief Investigators to support the delivery of research studies and clinical trials.

Support the Head of Research Delivery in the review and development of standard operating procedures relating to processes involved in the delivery of clinical research.

Monitor performance of the relevant portfolio providing progress reports and identifying opportunities for improvement and any actions to eliminate barriers to timely recruitment to trials.

Ensuring efficient and effective data management, undertaking routine data quality validation checks.

Appropriately delegate duties and supervise the performance of any allocated data management or administration staff.

Ensure all data are handled and processed in accordance with the Data Protection Act, Caldicott Guidelines and Trust Information Governance policies and procedures.

Act as a point of contact for internal and external BRC, ECMC and CRF contacts and any other external agencies as reasonably required.

Co-ordinate the preparation and publication of data, reports and information, ensuring that these meet legislative, contractual and ethic requirements.

Provide expertise in the application of clinical trial legislation and ICH GCP guidelines in the implementation of clinical trials and other research methodologies.

Liaison with commercial research sponsor organisations, auditors, monitors, and inspectors regarding compliance with Research Governance, ICH GCP, Data Protection and Ethical requirements.

Manage workload priorities ensuring effective management of urgent and important tasks that are completed within required timescales. To be proactive in the identification of workload or process issues that affect clinical service provision and, develop and implement action plans to resolve the issues.

Represent the R&I directorate at appropriate meetings, conferences and events.

To be instrumental in supporting the renewal of the bids for BRC, ECMC and CRF.

Financial Management

Work closely with the R&I Finance Team to ensuring that funding organisation(s) are invoiced and that monies are received into the specified budget that are relatable to the work stream.

To prepare and review contracts that are required to align CRF, BRC and ECMC.

People Management

Provide line management duties for support staff as designated by the Head of Research Delivery.

Undertaking annual appraisals and regular 1 to 1 sessions with designees in order to monitor performance and support professional development.

Maintain oversight of the performance of research studies supported by designated staff and work with them to resolve any issues as required.

Training and Education

Disseminate knowledge and experience in the application of clinical research to current UK legislative and regulatory requirements including current best practices. Acting as a source of knowledge and professional support to the wider team.

Administration

Administer internal and external BRC, ECMC and CRF meetings. Preparing the agenda, minuting the meetings, preparing and monitoring action plans.

Planning and supporting meetings associated with research delivery and portfolio performance management.

Ensure production and submission of annual trial reports across the portfolio are done in compliance with designated timeframes.

Ensuring any data requests for BRC, ECMC and CRF activity are dealt with in a timely manner and stipulated deadlines meet.

Undertake any other duties commensurate with the role and band.

Communications and Relationships

Manage time and resources effectively including chairing relevant meetings, taking minutes and keeping accurate records.

To work as part of the R&I Senior Management Team and contribute to the ongoing development and delivery of the CCC Research Strategy.

Deputise for the Head of Research Delivery at meetings as directed.

The postholder will be expected to communicate with a wide range of stakeholders including the most senior personnel, both internally and externally. The post holder must have excellent presentation skills with the ability to express coherent and convincing views, verbally and in writing.

To undertake the role will require developed communication skills to enable key messages of the project to be cascaded effectively to stakeholders. Skills of persuasion, negotiation, tact and diplomacy will be required when communicating on behalf of the team.

The post-holder will be expected to demonstrate sensitivity and awareness of politically sensitive issues and the need to adjust styles and behaviours to accommodate different situations and cultures. There will be a regular requirement for advanced communication and negotiations skills in challenging situations internally and externally, overcoming adverse reactions and political pressures.

This job description is not intended to be an exhaustive list of duties, but it aims to highlight the typical key responsibilities of the post. It may be reviewed from time to time to ensure that it relates to the job as then being performed, or to incorporate required changes. This process will be conducted in consultation with the post holder in line with the Trust Job Evaluation Policy and Process.

Person Specification

Qualifications:

Essential

• Degree in a business, biomedical or health science related subject.
• Postgraduate qualification/working towards a masters or equivalent experience.

Desirable

• Project Management Training

Knowledge and Expertise:

Essential

• Specialist knowledge of research regulatory issues governing the conduct of clinical research: oGood Clinical Practice (ICH GCP) oUK Policy Framework for Health and Social Care Research oMedicines for Human Use (Clinical Trials) Regulations including all amendments oMental Capacity Act oHRA Approval Process
• Working knowledge of clinical study set-up
• Experience of working as part of an ECMC, CRF and/or a BRC. ?Experience of working on or setting up clinical trials ?Experience of research governance/feasibility and sponsorship processes of clinical research.
• Experience of writing SOPs/policies and training manuals for internal staff. ?Experience of contribution to large scale projects, spanning multiple departments.
• Demonstrable knowledge and the role of MHRA/HTA inspection, audits and clinical trials monitoring.

Desirable

• Experience in costing clinical research and knowledge of Department of Health's 'Attributing the costs of health & social care Research & Development' (AcoRD). ?Experience of working on early phase clinical trials. Experience of working on advanced therapy studies (ATIMP).

Key Skills and Attributes:

Essential

• Excellent verbal and written communication skills. Enthusiasm about clinical research to lead and train R&I staff.
• Highly organised with the ability to work under pressure and take ownership of problems, prioritise their own wor
• Ability to influence others and negotiation skills. Ability to lead and motivate others. ?Ability to operate independently within a team environment. ?Ability to work with multidisciplinary teams.
• Competent IT skills including Microsoft Office.
• Ability to manage multiple projects and demonstrate prioritisation skills in order to meet deadlines. ?Ability to adapt in order to meet unexpected developments or situations that may arise. ?Able to implement effective change or R&I service improvement. ?Ability to interpret new regulatory or legislative requirements, interpret and communicate changes to staff as well implement changes to business processes in order to maintain compliance. ?Ability to summarise complex information and convey to internal and external stakeholders.

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.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Employer details

Employer name

The Clatterbridge Cancer Centre NHSFT

Address

Clatterbridge Cancer Centre

65 Pembroke Place

Liverpool

L78YA

Employer's website

https://www.clatterbridgecc.nhs.uk/ (Opens in a new tab)