Manager Clinical Data Management

This is an exciting opportunity for an experienced professional to step into a leadership role within a dynamic clinical data management organisation. The company, EDETEK, is seeking a Manager of Clinical Data Management to oversee crucial aspects of their clinical trial services. This position requires a blend of hands-on data management expertise and strong leadership capabilities, focusing on ensuring the quality and timely delivery of data management solutions.

About the role

As the Manager of Clinical Data Management, you will be at the forefront of managing clinical data operations and implementing systems. A significant part of your responsibility will involve leading the clinical data management team, ensuring they are equipped to handle project management documentation and execute all necessary data management activities. You will also play a key role in the system implementation of EDETEK’s CONFORM eClinical platform, which includes writing detailed design specifications for various system components like forms and reports, and facilitating the testing of these implementations.

While leadership is paramount, this role also demands staying actively involved in the day-to-day operations of clinical data management. You will be responsible for overseeing data management projects from start to finish, ensuring they meet stringent quality standards, are delivered on schedule, and foster ongoing client satisfaction. This involves not only managing projects but also proactively identifying client needs and devising innovative solutions that leverage the company's expertise, operational capabilities, and technological advancements. Effective communication with both clients and internal teams will be essential for success.

The core of your function will revolve around ensuring the integrity and efficient management of clinical trial data. This includes:

• **Project Oversight:** Leading and overseeing data management projects to guarantee quality, timely completion, and high levels of client satisfaction.
• **System Implementation:** Contributing to the implementation of EDETEK’s CONFORM eClinical system, including the creation of design specifications and user acceptance testing (UAT).
• **Operational Excellence:** Staying hands-on with clinical data management activities and operations, ensuring adherence to best practices and regulatory requirements.
• **Client Engagement:** Acting as a primary point of contact for clients, discussing project requirements, addressing issues, and delivering contracted services effectively.
• **Team Leadership:** Selecting, interviewing, training, and mentoring junior team members, fostering a collaborative and high-performing data management team.
• **Process Improvement:** Assisting in the development and maintenance of systems and infrastructure that support project operations.
• **Documentation Management:** Ensuring all required documentation is meticulously filed and maintained according to industry standards.
• **Data Management Plans:** Working collaboratively with Clinical Data Specialists to develop and execute comprehensive Data Management Plans.

What they're looking for

Candidates for this position should possess a solid understanding of Good Clinical Data Management practices, including the associated documentation requirements. Experience with both the start-up and wrap-up phases of in-house and client-specific data management projects is highly valued. A strong grasp of relevant therapeutic indications, study hypotheses, and trial designs will be beneficial, as will a thorough understanding of database design and structure.

Essential qualifications and skills include:

• A Bachelor’s degree or an equivalent combination of education, training, and experience.
• A minimum of two years of experience in clinical trials, clinical data management, or a similar industry role.
• Demonstrated experience or a strong understanding of the entire data management lifecycle for a clinical trial is desirable.
• Working knowledge of Electronic Data Capture (EDC) studies and SAS.
• Exceptional communication skills in English, with the ability to articulate complex information clearly.
• A keen eye for detail and a commitment to accuracy in all tasks.
• Excellent organisational skills and the proven ability to manage multiple projects simultaneously.
• The capacity to work both independently and collaboratively, taking initiative and meeting deadlines consistently.
• Advanced computer proficiency, including practical experience with MS Office Suite.
• A willingness to travel occasionally (approximately 5%) may be required.

In South Africa, roles like this often fall within Contract Research Organisations (CROs) and pharmaceutical companies. While specific salaries vary widely based on experience, location within SA, and the specific company's structure, a managerial position in clinical data management could typically expect a competitive salary package, often in the range of R500,000 to R800,000+ per annum for experienced individuals. Career progression can lead to more senior management roles, or specialisation in areas like data science or regulatory affairs within the clinical research sector.

• A Bachelor’s degree or equivalent combination of Education/Training/Experience is required
• A minimum of 2 years of clinical trial or clinical data management experience or similar industry experience/training is required
• Prior trial responsibility for the entire data management life-cycle is desirable
• Working knowledge of EDC studies and SAS is required
• Some travel (5%) may be required