SOURCE DOCUMENT MANAGER
Closing date for applications: 24 November 2022
HYBRID/MANCHESTER - FULL TIME
To provide line management to the Source Document team and Source Document expertise to support MAC Clinical Research and its customers.
To lead and manage assigned line reports within the Source Document team to allow the delivery of high quality and timely deliveries of source documentation for all clinical trials at MAC sites.
To develop best working practices and Standard Operating Procedures to deliver source documents for the portfolio of projects within MAC Clinical Research in line with relevant SOP’s and in accordance with ICH-GCP.
KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED:
Educated to Degree level (or equivalent) in an area relevant to the role (essential)
Previous experience in data management or in using Electronic Data Capture systems (essential)
Excellent oral and written communication skills (essential)
Self-motivated with the ability to work with minimal supervision and with proven experience of delivering successful outcomes across internal teams (essential)
Demonstrates knowledge of ICH-GCP (desired)
Demonstrates a sound knowledge of ALCOA-C principles (essential)
Excellent planning, attention to detail, organisational and time management skills (essential)
Excellent analytical and problem-solving ability (essential)
Understanding study protocols and the ability to interpret into effective source documents (essential)
Able to work to strict deadlines(essential)
Excellent document creation and manipulation skills (essential)
Oversee assigned Source Document team to ensure delivery of high-quality deliverables, on time and in-line with protocol requirements and medical experts achieving a high level of data capture quality and subject experience.
Ensure all protocol requirements, project plans, SOP’s and regulatory requirements are adhered to.
Define and manage resource allocation within assigned team to ensure that the Source Document project portfolio can be delivered effectively on time, to a high quality. Confirm sufficient and qualified staff capacity to meet new business targets, define new departmental resource needs.
Support the preparation, management, attendance and responses for QA audits (internal & external) in an appropriate and timely manner.
Input into the Source Document SOPs and their provision of clear, structured processes to meet business needs.
Perform regular review of training records for staff and ensure that job descriptions, CVs and training records are up to date.
Conduct Personal Development Reviews across assigned team. Support the recruitment of experienced, qualified new members of staff.
Proactively identify risks and issues and devise mitigation and contingency plans, solving problems as they arise. Encourage team members to apply the same proactive approaches to solutions.
Support the ongoing training and development of the source document team
Share experience and knowledge with team members
Source Document Lead
As needed, perform the Source Document role across multiple studies and sites, delivering high quality outputs according to MAC processes, ICH-GCP, the project timelines.
Perform or oversee:
Advanced project oversight, planning and delivery from a Source Document perspective, working with Clinical, Project Management, Data Management and Site teams within MAC Clinical Research.
Liaise with all sites ensuring reviewed and approved Source Documents are delivered for use at clinical visits.
Manage and perform expert review of Source Documents, ensuring all deliveries are of high quality and satisfy protocol requirements.
Identify areas of improvement to increase data quality.
Prioritise and monitor workload to ensure the correct studies are being focused on at the correct time
Allocation of work to the source document team
Liaising with all sites as required ensuring documents are ready in good time for clinical visits and ensuring adequate review process is adhered to.
Lead and contribute to ongoing Source Document quality process and system improvements.
Define and implement project specific strategies to allow the production of high-quality deliverables. Identify and resolve issues related to Source Document aspects of projects.
Compliance with MAC health and Safety policy
Compliance with MAC policy on equality and diversity
To maintain professional qualifications required for the role, including continuous personal development
To work to the requirements of SI 2004 no 1031 and amendments thereof, which includes Good Clinical Practice
To work according to MAC SOPs, guidelines and policies
To work according to current data protection standards and practice good information management. Maintenance of strict confidentiality of patient and business related data.
To maintain a high level of initiative and personal responsibility, liaising appropriately with team members and managers to ensure your job role is efficiently carried out
To support the aims of MAC and to represent MAC appropriately in a professional way to all our customers
Competitive salary in keeping with pharmaceutical industry standards and will reflect experience
25 days annual leave plus bank holidays (increasing in increments to 30 days after 6 years long service)
Your birthday off work
MAC Clinical Research invites applications from highly motivated candidates, with a desire to achieve their full potential. You will be working within an organisation that sees you as an investment and is keen for you to achieve your career aspirations.
Salary: Competitive + Negotiable £ Apply Now