Senior eClinical Business Lead - based in select European locations/South Africa

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

This role can be flexibly based in selected European and South African locations.

Role context:

The role leads the implementation of the eClinical Platform on study level ensuring timely start-up, quality delivery, and compliance with the study protocol and client contracted services. The senior eClinical Business Lead has global responsibility for the design, requirements gathering, requirements documentation, and the accountability for the implementation of technology to meet the specific needs of the assigned trials. This individual will work with Parexel’s standard technology. The Senior eClinical Business Lead provides training and mentoring to the more junior individuals, and take on the more challenging and complex accounts, and may provide work direction to eClinical Business Leads

Role responsibilities

Project Delivery:

• Lead the implementation of the eClinical platform on trial level

• Train and mentor more junior eClinical Business Lead

• May provide work direction to more junior eClinical Business Leads

• Take ownership for the more complex and challenging accounts

• Serve as the primary point of contact with the project team for trial-level technology, and data integration solutions, covering CRS, IT, and technology third party vendors

• Analyze protocols and collaborate with all stakeholders to create and review user requirements and integration needs

• Identify and mitigate any risks related to system set-up and integrations with internal systems and/or sponsor systems

• Be accountable for all technology set-up for assigned trials; this includes working with colleagues across departments who have specific responsibilities for part of the set-up

• Coordinate the teams responsible for delivery of the technology for a trial, including design, using standard components, based on customer requirements, planning and coordination of delivery of the technology and input to the overall project plan

• Ensure the quality, timeline and budget related to the trial technology meets the project requirements

• Set-up trial technologies if appropriate

• Ensure project team satisfaction of the trial technology solution

Client Management:

• Interact with external clients as needed for discussion on technology set-up, modifications, and integrations

• Demonstrate a proactive approach to providing solutions in a timely manner

General Administration:

• Maintain a positive, results oriented work environment, modeling teamwork and communicating with team members in an open, balanced, and objective manner

• Maintain a working knowledge of applicable ICH Guidelines and Good Clinical Practices

Role requirements:

• Proven significant work experience in a CRO/Pharma setting (operational or technical)

• Proven experience in clinical trial systems (e.g., CTMS, EDC, RTSM) with detailed understanding of requirements gathering, documentation, configuration, and integrations

• Knowledge in clinical research industry, including detailed understanding of clinical technology, design, and system requirements

• Proven record of influencing a team to deliver according to a schedule

• Experience of mentoring or providing work direction to staff

• Ability to motivate and work effectively with virtual teams within different cultural environments

• eCOA, ePRO experience is a plus

• Knowledge/experience of data standards such as CDISC SDTM is a plus

• Strong project management skills

• Educated to degree level in life sciences and/or computer sciences

• Fluent English

• Proven ability to manage independently competing priorities with attention to detail

• Ability to resolve issues independently with good judgement to escalate appropriately

• Proven awareness/experience in the needs and use of data standards in clinical trial environment

• Client focused (internal and external) and demonstrating an ability to create and maintain trust with clients

• Knowledgeable in ICH and GCP regulations in relevant geographies

A little about us:

Highly qualified and dynamic team. Multinational working environment. Smooth induction and training program.  We offer competitive financial packages, training, and development. Expect exciting professional challenges but with a healthy work/life balance. We value your welfare just as highly as that of our patients.

Parexel has a fully flexible work arrangement - you can be fully home based. But if you live close to our office and you want to use it, you are always welcome, and we will keep the desk ready for you!

We are unable to sponsor or take over sponsorship of an employment Visa.