Description:
- In Roche’s Pharmaceutical Research and Early Development organization (pRED), we make transformative medicines for patients in order to tackle some of the world’s toughest unmet healthcare needs. At pRED, we are united by our mission to transform science into medicines.
- Together we create a culture defined by curiosity, responsibility and humility, where our talented people are empowered and inspired to bring forward extraordinary life-changing innovation at speed.
- In Clinical Operations (CO), we aspire to be a leading edge organization that drives innovative patient-centric approaches in study design and execution, utilizes advanced analytics to drive data-driven decisions, and embeds innovative technologies into our ways of working to drive productivity and delivery of programs and studies.
- We strive to create a workplace where team members own their own development and learning and are empowered to create and innovate.
Job Mission:
- As part of the CO Expert Cluster the Clinical Trial Expert is accountable for a range of areas driving all phases in the execution of trial(s).
- The role will require enterprise wide interconnectivity and networking and monitoring of the internal and external environment.
- They are responsible for the delivery of operational portfolio activities in support of the Programme Management Cluster within timelines, budget, quality while contributing towards improving productivity and approaching study delivery from a patient centric mindset.
- The Postholder will be accountable for delivering strategic components within their area of expertise that improve productivity metrics of CO.
Your Impact:
- You work with the study teams to deliver clinical studies according to the expected and specified quality standards, within timelines and budget by the following:
- Providing support to the Cluster and a multi-disciplinary team which meets regularly with the aim to oversee early phase study activities across a range of disease therapeutic areas.
- Supporting the implementation of system, tools, and reports required during study execution, including input into requests for proposal, authoring of documents and potentially site personnel training.
- Leading Study Teams during specific phases of the study and/or accountable for the full implementation of certain study types.
- Initiating, maintaining and reconciling Trial Master Files in accordance with SOP requirements.
- Supporting Service Provider management, in close collaboration with the Study Leaders, including logistics, meeting management, etc., as needed.
- Collaborating with Study Leaders and Clinical Trial Experts on the development of study-specific activities plans and/or processes.
- Supporting pRED Clinical Operations with activities to improve patient centricity and increase productivity in clinical trial execution; may also include participating in departmental initiatives.
Your Profile:
- You are talented and passionate. You are inspired by our mission and would fit in well with our collaborative, patient centric and entrepreneurial spirit.
- Have a growth mindset and are excited about learning through experienc
- Feel comfortable thinking on your feet and thrive in fast paced, ambiguous and highly collaborative environments
- Have experience in pharmaceutical and/or healthcare industry and drug development experience (therapeutic area experience a plus)
- Hold a university degree or equivalent years of experience, preferred focus in life sciences
- Find passion in achieving successful outcomes by leading, coaching and inspiring others
- Want to make a difference and find excitement in innovating practices, therapeutics and processes
- Experience in working across the clinical trial lifecycle with a solid understanding of the clinical trial environment, including ICH-GCP as well as the sequence and interdependencies of the clinical trial management
- Experienced in the clinical trial management tools and systems and their interdependencies e.g. IxRS, eCOA, centralised endpoint review (images, ECG or else), digital biomarkers etc.
- A solid grounding in business performance improvement methodologies including project conceptualisation, situational analysis, solution design, implementation and continuous improvement.
- Ability to collaborate with a range of stakeholders in the implementation of the strategic direction for the respective early development clinical studies.
- Proven ability to contribute and/or lead specific areas of trial execution within the agreed upon timelines
- Strong interpersonal skills, written, oral communication and negotiations skills. Must be highly organised and detail-oriented.
- Strong problem solving skills and analytical skills.
This is the pay range that Magnit reasonably expects to pay for this position: $61.29/hour-$81.71/hour
Benefits: Medical, Dental, Vision, 401K (provided minimum eligibility hours are met)
Magnit has an ongoing commitment to the diversity and inclusion of all team members. We believe that embracing diversity leads to innovation and helps address the needs of the business. We welcome individuals from different backgrounds, experiences, and cultures to join our team. We value this diversity and strive to create an inclusive environment that celebrates these unique perspectives, allowing you to contribute to your full potential. Finally, but most importantly, we expect all team members to be treated with dignity and respect.
If you have a disability and need an accommodation in relation to the online application process, please email us at Roche.Accommodations@magnitglobal.com
