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Clinical Study Manager Job Description

What does a Clinical Study Manager do?

A Clinical Study Manager is responsible for overseeing clinical studies and trials within the healthcare sector. This involves managing the planning, execution, and monitoring of the study process, including coordinating with study personnel, ensuring adherence to ethical and regulatory requirements, and ensuring that data is collected accurately and efficiently. The Clinical Study Manager is also responsible for reporting study progress to senior management and making key decisions that impact the study’s success. They may work in various healthcare settings, including hospitals, pharmaceutical companies, and research institutions. Overall, the Clinical Study Manager plays a crucial role in advancing medical research and improving patient outcomes.

Our Clinical Study Manager job description includes the Clinical Study Manager responsibilities, duties, skills, education, qualifications, and experience.

Clinical Study Manager Example

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If you need an example job description for a Clinical Study Manager download the one below, alternatively we have many other Healthcare job description samples and a job description library with over 3000 job descriptions templates that you can download for free.

What does a Clinical Study Manager do?

The Clinical Study Manager is an integral part of a Clinical Trial Team, managing clinical studies from start to finish in accordance with Good Clinical Practice (GCP) guidelines. Responsibilities include the coordination, management and oversight of all study-related activities, including study design and protocol development, budget management, vendor selection and management, and site monitoring. The Clinical Study Manager will also be expected to maintain accurate study records and ensure that all data is collected and reported in accordance with applicable regulations and guidelines. The successful candidate will have excellent organisational, communication and problem-solving skills and be able to work independently and as part of a team.

Clinical Study Manager Role Purpose

The purpose of a Clinical Study Manager is to plan, coordinate and manage clinical studies and related activities in accordance with regulatory requirements and best practice. This involves developing study protocols, collaborating with other study personnel, monitoring study progress, and ensuring the quality of data collected. The Clinical Study Manager is responsible for ensuring that the study adheres to applicable regulatory requirements, complies with GCP (Good Clinical Practice) guidelines, and is conducted in accordance with the study protocol. This role also involves managing study budgeting and vendor contracts, preparing regulatory documents, and interacting with study sponsors and internal departments.

Clinical Study Manager Role

The Clinical Study Manager is responsible for overseeing and managing the clinical study lifecycle from project initiation to completion. This includes developing and managing study protocols, budgets, timelines, and other operational activities. The Clinical Study Manager will also be responsible for training and managing research staff and ensuring that regulatory requirements are met.

Clinical Study Manager Duties

  • Organise and co-ordinate clinical studies and trials
  • Assess and review clinical data
  • Develop clinical trial protocols and documents
  • Plan and manage budgets
  • Source and liaise with clinical trial sites
  • Monitor study progress and quality
  • Ensure compliance with regulatory standards
  • Analyse and report study results

Clinical Study Manager Requirements

  • A degree in life sciences, healthcare or a related field
  • Knowledge of Good Clinical Practice (GCP) guidelines
  • Experience in clinical research or drug development
  • Excellent communication and organisational skills
  • Ability to work in a fast-paced environment

Clinical Study Manager Skills

  • Project Management
  • Organisational Skills
  • Problem Solving
  • Attention to Detail

Clinical Study Manager Personal Traits

  • Excellent communication skills
  • Attention to detail and accuracy
  • Organised and self-motivated
  • Ability to work independently and as part of a team

How to write a Clinical Study Manager Job Advert

Use our job advert template to write a job advert for posting on job sites and job boards. Our job advertising templates are carefully created to help you reach your audience and beat the competition to the best talent.

A job description informs the reader about a job, whereas a job advert’s main objective is to sell the job opportunity to attract as many suitable applicants possible. A job advert maybe the first touch-point a candidate has with your company so it is important to create a great impression.

Job Advertisements should enticing, so considering using short, exciting language which get the reader’s attention.

How to write a Clinical Study Manager Job Description

To write a job description, we recommend starting with a job description template from our job description library, which contains examples for 800+ positions and professions. Our job description examples include a job summary with duties and responsibilities and skills and requirements, which can be personalised for your job vacancy.

Job Description Advice - Guidance on How to Personalise a Clinical Study Manager Job Specification

The hiring process and recruiting new employees to fill your key roles requires a degree of personalisation if you are to attract the best employees in a competitive employment market. The right person for a crucial role or more senior roles will likely have other employers targeting them. As your job description will be the first point of contact, you need to nail your pitch and provide the best possible service.

Job Description Tips - Help on formatting a Clinical Study Manager Job Specification

When creating your bespoke description and advert, you should cover and promote these points:

Job title: This should accurately reflect the role and include keywords that top talent might be using to search for jobs.

Job duties: The day to day duties, such as administrative tasks, which vary depending on the company and inform the candidate if they can complete the role.

Technical skills: These are the hard skills required through training, such as proficiency with Microsoft Office.

Soft skills: These include the interpersonal skills and general abilities the right candidates will possess. For example, the competency to prioritise multiple tasks, handle customer queries and customer complaints, work alone, or build a good relationship with coworkers.

The company's culture: Highlighting your company culture and values ensures employees thrive and find outstanding job satisfaction. Candidates that are not the right fit won’t waste their time completing the application process, meaning you can focus on qualified individuals and hire in a more timely manner.

Career progression: Including the career path will entice candidates looking for career growth. 

Training and development programs: Smaller companies may need employees with previous experience or provide educational assistance over internal training offered by larger organisations with more significant resources. 

Employee benefits: Compensation and benefits often fail to appear in job ads and while you may want to hold your cards close to your chest, failing to include them is a mistake. Consider answering common questions, such as working hours and paid leave. Researching the average salary for the role in these early stages will ensure you don’t waste your interviewer’s and the candidate’s time.

Skill gaps: Your company may need to bring in new skills beyond those required to complete the key role and duties. Thinking on an organisational level can be beneficial when contemplating skills diversity.

Legal requirements: Ensure your job advert and description does not ask for inappropriate or discriminatory personal details, such as age, marital status, or religion.

How to Hire a Clinical Study Manager

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