Study Workflow Manager – Ruminant Research Trials Ruminant Biotech Corp Ltd (RBT) has one purpose, to make a big difference in climate change by materially reducing the amount of methane put into the atmosphere by ruminant livestock (Cattle, Sheep, Deer, Goats). We are at the cutting edge of biotech, developing sustained release products to eliminate methane production in ruminants. This is a challenging design problem, involving the intersection of both materials' science and chemistry. RBT's research trial programme aims at establishing a fundamental understanding of mode of action as well as characterizing early prototypes with respect to their efficacy and safety both in the field and in vitro. The role is to manage the overall workflow of field trial execution. This comprises designing and aligning study plans with internal and external stakeholders, managing ethics applications, tracking study execution as well as reporting on completed studies.
The Role
You will be part of the research trials team which plays a key role in bringing RBT's innovative methane mitigation platform to market. You will work alongside a field trials operations manager, field technicians, technical writers, and biometricians. You will also have routine interactions with RBT's product development team, regulatory affairs, and other functions relevant to your work.
Your role is to be the administrative owner of several research activities with a strong focus on field trials. For your trials, you will facilitate internal alignment on study plans and protocols and author the corresponding documents. For external trials, this involves interaction with RBT's service providers. Wherever required, you will furthermore author and manage animal ethics applications. You will track and monitor your running trials through regular exchange with field trial operations and escalate issues requiring alignment. You will ensure that trial documentation is complete and matches the requirements of study plans and protocols, and is authorized under the required documentation process. Wherever in scope, you will prepare a final study report with the help of biometricians and analysts as appropriate and manage the internal review process.
Depending on your background and affinities, you will also have the opportunity to impact and improve RBT's systems and trial protocols and implement innovative approaches.
The role is suited for candidates with a wide variety of backgrounds. A strong focus on organizational skills and delivering to deadlines is required, with project management experience considered valuable. A further key qualification is an effective way of authoring scientific study protocols and documentation as well as a proactive style of working and planning. Previous experience in running animal trials would be highly beneficial.
Tasks
Assume ownership of several field and/or in vitro trials and establish an understanding of key trial objectives
Facilitate and moderate the discussion of your trials during regular trial planning sessions, align with internal and external stakeholders
Prepare trial plans and protocols and manage their internal review, approval and change management
Prepare and submit animal ethics applications, manage feedback received from animal ethics committees
Accompany trial execution by close interaction with field trial operations and farm technicians – escalate issues requiring alignment
Manage interactions with external service providers wherever applicable
Ensure documentation matches RBT's standards and specific trial requirements
Prepare final trial reports and manage the review and approval process assuring appropriate stakeholder input
Qualifications and Experience
Academic qualification in a relevant scientific discipline, minimum: MSc, desirable: PhD
Demonstrated experience in study and/or project management with at least two years of relevant experience
Demonstrated strong technical writing skills
Experience in animal trials in general and ruminant trials in particular is highly desirable
#J-18808-Ljbffr