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Job Description
At Quanticate, we&aposre pioneers in providing top-tier statistical and data management support to our clients. We&aposre seeking a dedicated "Clinical Data Manager I" who&aposs 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.
- 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
- Allocation of projects in conjunction with Project Management, as appropriate
- Performance reviews, as required.
- Administer training and development of staff, as required.
- 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.
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.
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- 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
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)
Skills
RecruitmentTraining And DevelopmentIf an employer asks you to pay any kind of fee, please notify us immediately. Jobaaj does not charge any fee from the applicants and we do not allow other companies also to do so.
About Company
Quanticate is a leading global data focused clinical research organisation (CRO) primarily focused on the management, analysis and reporting of data from clinical trials and post-marketing surveillance. As experts in clinical data, Quanticate provides high quality teams that offer efficient outsourcing solutions for:
• Clinical Data Management
• Biostatistics
• SAS Programming
• Data quality oversight via Centralized Statistical Monitoring
• Medical writing
• Pharmacovigilance
Quanticate can offer study level support, functional service provision (FSP), strategic full data-services solutions or technical consultancy to meet the needs of pharmaceutical, biotechnology and device companies across the globe. Quanticate has become the supplier of choice for many companies from top tier pharmaceutical giants through to niche biotechnology and device companies. Quanticate also have a staff recruitment arm, "Envalis", to help Sponsors find all types of permanent and contract staff.
With offices across three continents, we have a global reach and offer customer focused solutions from fixed cost or functional service provider (FSP) models through to consultancy.
By offering high quality, value-added flexible solutions that meet current and future development needs, Quanticate has become the trusted supplier of choice for many companies from niche biotechnology and device companies to top tier pharmaceutical giants.
We pride ourselves on having strong values to which all our staff work towards every day. From caring about our staff (and each other) to being honest and transparent in our daily dealings coupled with being treated with respect, Quanticate is a great place to start or continue to develop your career.
We live by six core values that reflect who we are aspired to be; they determine our priorities and drive our behaviour and actions.
Important dates & deadlines?
Application Deadline
27 Oct 25, 05:10 PM IST
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