Job Openings at Clintec

Responsibilities Of The Clinical Research Associate (CRA)

• Perform all types of site visits (selection, initiation, interim and close out)
• Work in accordance with company SOPs, GCP guidelines and country specific regulations
• Site management activities to ensure adherence to protocol, SDV and CRF
• Develop, collect, review and edit clinical trial documentation
• Assist in protocol design as and when required
• Ensure adequacy of drug shipment and drug accountability
• Liaise and form positive working relationships with all colleagues, study site staff and sponsor representatives
• Work closely and provide support to the study Project Manager
• Organise and/or attend investigator meetings

Criteria

• Bachelor’s degree level (or equivalent) within Medicine, Biological Sciences, Pharmacology, Nursing or relevant life science discipline
• Significant experience within CRA role across a range of therapeutic areas
• Work experience within a pharmaceutical company or CRO setting
• Good working knowledge of ICH GCP and local regulatory requirements
• Ability to independently perform all types of site visit (selection through to close out)
• Fluency in English and Afrikaans languages required
• Willing and able to travel to sites across South Africa

Why Work For Clintec?

At Clintec, we believe our people are our greatest asset and understand that the best performance comes from individuals who know they are part of a valued team. You can expect to receive expert training and guidance throughout your career with us, with the opportunity to develop, progress and travel globally.

We Can Offer You

• A competitive salary and benefits package
• The opportunity to work with various global pharmaceutical leaders on the some of the most prestigious, ground-breaking and challenging drug development projects
• Real career development opportunities and a life-long career with an innovative, forward-thinking clinical research company

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The Role

As a Clinical Research Manager, you will work fully dedicated to our sponsor, a leading global pharmaceutical company, and be responsible for the end to end performance of your protocols at a country level.

Responsibilities Include

• Project management of studies; planning, driving and tracking the execution and performance of deliverables/timelines through all stages of the trial to meet country commitments
• Reviewing monitoring reports and escalating performance issues and training needs of CRAs
• Perform Quality Control Visits
• Leading local study teams; coordinate activities across local roles, closely work with and support CRAs, provide protocol training and act as a protocol expert
• Creating and executing local risk management plans
• Ensuring compliance with key systems such as CTMS and eTMF
• Collaborating with external partners including investigators and functional outsourcing vendors as well as internal functions (PV, Regulatory etc.)
• Building business relationships with investigators

Requirements
To be successful in the role of Clinical Research Manager you will have:

• Extensive clinical research experience, including previous experience as a CRA and knowledge of project management
• Bachelor’s degree in Scientific field
• Proven understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously
• Ability and skills to manage resource allocation, processes, productivity, quality and project delivery
• Ability to make decision independently and collaborate across countries remotely/virtually
• Knowledge of local regulatory environment
• Strong leadership skills
• Fluency in English and Afrikaans
• Ability to work office-based in Johannesburg

By Joining The Clintec Team You Can Expect

• Competitive salary and benefits packages for permanent employees
• Opportunity to work with global pharmaceutical leaders in roles fully dedicated to a single sponsor
• Opportunity to work on ground-breaking, challenging studies in various therapeutic areas
• Real career development opportunities within a friendly and sociable team where you can truly shine and make an impact