Job Description

At Quanticate, we're pioneers in providing top-tier statistical and data management support to our clients. We're seeking a dedicated "Clinical Data Manager I" who's committed to upholding the highest standards, following procedures, and ensuring compliance with regulations, all while providing exceptional customer care.

As a "Clinical Data Manager I" you will lead, co-ordinate, and action all tasks relating to Clinical Data Management from the start to the finish of a study & to project manage studies across CDM functions.

Core Accountabilities:

Activities required of a Clinical Data Manager I (however not restricted to) are as below:

• To contribute to the efficient running of the CDM department as part of the CDM leadership team.
• Ensure launch, delivery, leadership and completion of all CDM procedures according to contractual agreement and relevant SOPs, guidelines, and regulations
• To pro-actively keep abreast of current clinical data management developments and systems
• To assist in the creation and review of in-house SOPs.
• To research and provide input into in-house strategies and systems.
• To perform medical coding activities on projects, if assigned.
• To perform other reasonable tasks as requested by management.
• Ensure consistency of process and quality across projects.

Project management for allocated projects:

• To help plan and manage study timelines and resources.
• To manage progress against schedules and report to management.
• To perform project management across all functions for a study as appropriate.
• Management of CRFs and all related tasks

Management of allocated staff:

• Allocation of projects in conjunction with Project Management, as appropriate
• Performance reviews, as required.
• Administer training and development of staff, as required.

Key Relationships:

• Act as the primary CDM contact, both external and internal, for Quanticate projects.
• Manage work assignment and delivery of project tasks to the data processing and programming team as required
• Line management responsibilities for any assigned direct reports, including professional development/training and performance appraisals.

Quanticate is the world leading data-focused CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical programming, statistics and data management input. We need talented individuals to help us fulfil our customers’ needs.

Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical program, to small biotechs that are taking their first steps in clinical development

We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want – developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.

Requirements

• Qualified to an appropriate standard, preferably to degree level in a life sciences subject

• Six to Eight years of relevant experience in CRO Clinical Data Management domain, including leading studies.

• Extensive knowledge of at least 2 Clinical Data Management systems such as Oracle Clinical, Medidata Rave, Inform

• Thorough knowledge of ICH Guidelines and GCP including regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing

• CDM project leadership, strong communication skills

• Sound knowledge and experience on pharmaceutical industry and requirements for delivery of clinical trials

• Proven ability in client relationship management

Quanticate will never ask for payments as part of the recruitment or hiring process, and all legitimate correspondence from Quanticate will come exclusively from our @quanticate.com domain name. Hiring at Quanticate is based purely on merit and we do not ask or require candidates to deposit any money or complete any paid for courses as part of the process. Further guidance on our recruitment process and tips on how to stay safe during your job search can be found on our website at https://www.quanticate.com/careers-guidance

Benefits

◼ Competitive salary (Open to discussion based on experience)

◼ Flexible working hours

◼ Holidays (Annual Leave, Sick Leave, Casual Leave and Bank holidays)

◼ Medical Insurance for self and immediate family

◼ Gratuity

◼ Accidental Coverage

◼ Quanticate offers a variety of different learning development opportunities to help you progress (mentoring, coaching, e- learning, job shadowing)