Clinical Data Manager I

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, 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.

Requirements

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

• Four to seven years of relevant experience in CRO Clinical Data Management domain.

• 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
  

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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)