Clinical Data Managers

Healthcare Support

Level 5549 of 1200 points

Job description

Clinical Data Managers

Job purpose

To design and validate clinical databases and to process, audit and analyse the data they hold, directing the staff and plans supporting each study, so that clinical data is accurate, complete and delivered to end users and regulatory submissions on schedule.

Skills

Specialist knowledge of clinical data management: database design and validation, the design and testing of logic checks, data management planning covering coding, reporting, transfer and database locks, quality control auditing and statistical analysis, supported by programming skill and enough medical terminology to interpret the data handled. Bachelor's degree is the norm, with small minorities holding a master's, an associate's degree or a post-baccalaureate certificate, together with several years of related experience.
Confers with end users to define clinical system requirements such as data release formats, delivery schedules and testing protocols, and communicates programming needs to information technology staff in written technical specifications. Raises queries with those who supplied records, explains what the data means to functional areas such as clinical monitoring and medical affairs, and trains and directs project staff. Contact is by e-mail, telephone and face-to-face discussion, much of it inside a working group.
Resolves errors and omissions identified by validation checks and during data entry, designing and testing the checks that detect them, and audits the accuracy, completeness and proper use of clinical systems and data. Evaluates processes and technologies and proposes revisions to raise productivity. Problems are technical and largely governed by standard operating procedures and the study protocol, though database design and system evaluation call for judgement where no precedent applies.
Develops project-specific data management plans covering coding, reporting, transfer, database locks and workflow, and designs and tracks the paper and electronic forms through which data is received and processed. Schedules the work of project staff, monitors quality against standard operating procedures, and sets own priorities inside agreed delivery schedules and lock dates, under pressure of time.
Work is carried out seated at a workstation, using clinical database, statistical and office software. No manual handling or dexterity demands.

Responsibilities

Supervises the work of data management project staff, leading them on study activities, scheduling their work, training them on procedures and software, and monitoring productivity and quality. Accountable for their outcomes and for cooperation within the team; recruitment, appraisal and disciplinary duties are not evidenced.
No budget is held and no authority to commit expenditure is evidenced. Estimates the time, cost and resources needed for data management activities, and selects or develops software for particular research scenarios, influencing spend on tools without controlling it.
Ordinary care of a workstation, together with the clinical databases and data management systems the postholder designs, validates and maintains. No responsibility for premises, plant or stock.
Accountable for the integrity of clinical data: receipt, entry, verification and filing of records, resolution of queries, formatting of data sets on request, and preparation of analysis listings and progress reports. Writes the work instruction manuals, data capture guidelines and standard operating procedures governing how data is handled, and contributes to protocols, clinical study reports and regulatory submissions. Structure follows the study protocol and end-user specifications, within which the postholder designs the database and its checks.

Effort required

Sustained attention to exactness across large volumes of records, much of it repeating the same verification and reconciliation tasks, alongside the analytical work of designing logic checks and applying statistical tools. Decisions are frequent and taken under pressure of time against delivery and lock dates, with consequences for colleagues and study results.
Demand is one of accountability rather than emotional exposure: answerable for data supporting study reports and regulatory submissions, and for the output of project staff. Requires patience with detailed corrective work. No exposure to distress or hostility is evidenced.
Seated work at a workstation for most of the working day. No lifting or exertion.

Working conditions

Indoor, environmentally controlled office work, with no exposure to weather, noise, contaminants or hazard. The day carries a high volume of contact — e-mail throughout, frequent telephone conversations and face-to-face discussion — and close working within a project team and with parties outside the organisation.
Most incumbents work a standard week on a regular established schedule, with a substantial minority working longer and small minorities on irregular or seasonal patterns. Work is bounded by standard operating procedures, protocols and agreed delivery dates; within that framework the postholder has freedom to make decisions and sets own tasks and goals, answering for outcomes affecting co-workers and company results.

Skills

40% · 264 points▾

KnowledgeLevel 5 of 8
90 of 144 points
Specialised and theoretical knowledge within a field of work and an awareness of the limits of that knowledge. The job requires a comprehensive range of cognitive and practical knowledge to develop creative solutions to abstract problems.
Interpersonal and communication skillsLevel 3 of 5
58 of 96 points
Effective communication and interpersonal relationships. The job holder is required to adapt communication to different audiences and foster trust, cooperation and positive working relationships.
Problem-solving skillsLevel 3 of 5
58 of 96 points
Variable problems. The job involves dealing with different kinds of problems that require careful thinking, research into different options or adjusting existing ways of doing things. Guidance and resources may be limited.
Planning and organisational skillsLevel 4 of 5
58 of 72 points
Advanced organisational skills required. The job requires planning and managing complex, often overlapping tasks or schedules. The job requires a degree of autonomy and joint planning, and managing interdependencies across teams or departments.
Physical skillsLevel 0 of 5
0 of 72 points
Not applicable. The job does not require any particular physical skills (although there is likely to be some physical activity).

Responsibility

35% · 182 points▾

PeopleLevel 3 of 5
86 of 144 points
Moderate responsibility for people. The job includes overseeing or coordinating the work and well-being of others. This may involve supervising, providing regular support, managing conflicts, responding to an individual's needs and ensuring the personal and professional development of individuals.
Goods and equipmentLevel 0 of 5
0 of 84 points
Not applicable. The job does not involve any responsibility for goods or equipment.
InformationLevel 3 of 5
58 of 96 points
Moderate responsibility for information. The job involves managing information to ensure it is accurate, of high quality and secure. The job holder may make decisions about the handling of sensitive data.
Financial resourcesLevel 2 of 5
38 of 96 points
Limited responsibility for financial resources. The job involves handling limited financial resources, such as managing small budgets, processing invoices or participating in financial planning discussions.

Effort

15% · 79 points▾

Mental effortLevel 3 of 5
36 of 60 points
High level of mental effort. The job involves frequent concentration on complex tasks that require considerable mental effort, such as interpreting complex data.
Psychosocial and emotional effortLevel 3 of 5
43 of 72 points
Moderate psychosocial and emotional effort. The job requires the regular management of emotional responses, such as dealing with sensitive or challenging individuals or situations.
Physical effortLevel 0 of 5
0 of 48 points
Not applicable. The job does not require any physical effort.

Working Conditions

10% · 24 points▾

Environment (physical, psychological or emotional)Level 1 of 5
17 of 84 points
Minimal exposure to hazards or stress. The job involves little or no exposure to physical hazards (e.g. chemicals, moving equipment, noise) and minimal emotional or psychological risks (e.g. occasional routine tasks with no emotional burden). There is minor exposure to dust, dirt, fumes, noise, waste, poor lighting, etc.
Organisational environmentLevel 1 of 5
7 of 36 points
Minimal organisational demands. The job requires standard working hours with no night shifts or irregular schedules. There is little or no need for travel or digital connectivity beyond typical working hours.