This post will be responsible for management of essential documents and the setup of ESMS clinical trial services and medical information services.
Ensure that the physical and electronic document files used by the operations team to answer clinical trial and medical information enquiries are up to date and complete, that documents are filed accurately and are readily retrievable, and physical clinical trial study file indexes are up to date and complete.
Ensure superseded client documents are archived or disposed of as requested by the client and specified by ESMS record control procedure.
Maintain various indexes and lists used by the operations team to identify and retrieve documents until these are superseded by an electronic document management system.
Ensure clinical trial documents and files, and records of transactions relating to them, are managed in accordance with standards of Good Clinical Practice, and that documents and records relating to medical information services are maintained to a similarly high standard.
Be the focal point for communications with clients regarding documents received from them or returned to them and ensure records are complete and accurate.
Activate and test access to clinical trial data via interactive voice and web response services (IVRS/IWRS).
Be responsible for the setup of the service for new clinical trials from both current and new clients, communicating with the client as necessary to ensure efficient turn around between new trial notification and the service going live.
Collect and analyse key performance indicators, and prepare a range of reports on performance against specified targets.
Perform administrative tasks to provide day to day support to the operations team such as answering the general administration telephone enquiries, assisting with provision of hospitality, and taking post to and from the post office.
During occasional periods of staff shortage or sickness assist the operations team by message taking for incoming enquiries, as instructed by the Operations Manager or Deputy.
Perform general tasks to assist with the distribution and recording of training activities completed by the operations team.
Be familiar with and comply with all required procedures and work instructions related to the job role.
Participate in projects to improve processes and systems for information management.
Participate in internal audit and other quality improvement processes as appropriate.
Maintain an individual training file and electronic record of all training activities undertaken and be ready to demonstrate your training record at short notice for quality reviews and audits.
Attend team meetings.
Qualifications & Competences
Educated to degree level in a life science.
Basic understanding of the following:
The Data Protection Act.
MHRA Good Clinical Practice.
External quality standards and how they affect the service e.g. ABPI and PIPA.
Excellent interpersonal skills including:
Demonstrable ability to communicate clearly, concisely and accurately, both verbally and in writing, and to listen actively.
Ability to communicate with service users and clients at all levels.
Helpful telephone manner.
Good attention to detail and accuracy, striving for excellence in standards and methods of work.
High level of computer literacy particularly with Microsoft Word and Excel.
Proven ability to be self-motivating and self-reliant, to work independently when required, and manage own work priorities and deliver routine work within agreed timelines.
Maintain a culture which reflects ESMS Global values.
Ability to work in a team with drive and commitment to achieve team goals.
Demonstrable flexibility and adaptability; able to anticipate and embrace change.
Demonstrate enthusiasm for developing individual skills and knowledge.
Pharmacology as part of first degree or a proven interest in this subject.
Experience in the pharmaceutical industry.
Experience in medical information or drug safety would be particularly useful e.g. as a clinical trial administrator/assistant within a pharmaceutical company or contract research organisation.
Experience of working in a multidisciplinary team.
Experience of reporting key performance indicators through manipulation of data.
Evidence of innovation and creativity.
Understanding of documentation involved in the running of a clinical trial, and the ability to extract relevant information.