At Ora, we strive to deliver exceptional service by hiring driven team players that are intellectually curious, eager to learn, pursue growth, and have the stamina to make an impact in our fast-paced environment. Our team is made up of leaders who have successfully built numerous companies in life sciences and beyond. We are a family-founded organization that is an industry leader and innovator in the pharmaceutical services (CRO) space.
We value high performance teams, and we want to work with people that embody our foundational competencies:
Innovative: We believe that re-thinking the status quo is imperative and that new ideas can and should come from everyone on the team.
Collaborative: Every interaction, whether with a client or a colleague, should be impactful, respectful and leave them excited to work with you again.
Execution-Oriented and Accountable: The kind of change that is necessary will not come without breaking a few eggs, so we have the courage to be adventurous and try new things, but we also admit when something is not working, own it and do it better the next time.
The Head of Monitoring Services is responsible for the planning, resourcing, and the execution of Ora’s monitoring activities. This individual provides strategic oversight and operational leadership with a focus on the development and maintenance of accurate operational plans including department and project timelines as well as budgets. Furthermore, in collaboration across the organization, this individual will be responsible for planning, launching and monitoring strategies for growth (e.g. resource management models), strategies for new approaches to monitoring clinical trials (e.g. RBM, virtual trials) and strategies for being known as the ophthalmology CRO of choice by our research sites (e.g. robust training, onboarding and site management programs). This individual must have the ability to balance multiple variables associated with this highly collaborative, matrixed role.
This individual will supervise and mentor a team of monitors across the United States and Asia/Australia, both permanent and freelance, and play a critical role in ensuring that studies conducted by Ora are appropriately monitored to ensure adherence to all relevant SOPs, clinical protocols, and clinical management plans globally. Furthermore this individual will be responsible for collaborating with colleagues across the organization and globe to deliver consistently to our customers and research sites. While EU does not report into this role, this role will have dot line oversight of the monitors in EU, this individual will partner with the Head of EU/UK site head on ensuring consistency globally.
Supervises and coordinates Clinical Management functions, including mentoring managers in day-to-day activities and responsibilities related to the clinical deliverables. Ensures the clinical teams are provided with the necessary support and resources to successfully deliver clinical deliverables.
Ensures the timely execution of clinical deliverables with a focus on quality deliverables. In those cases, develops and drives the specific and overall project or program strategies to ensure optimum performance and achievement of annual plans and targets. Facilitates meetings to identify potential risks and work with the clinical team to develop and communicate contingency plans.
Ensures risks to clinical deliverables and potential solutions are communicated through appropriate escalation pathways. Reviews and assesses clinical project or program finances and ensures risks are escalated appropriately with any information necessary for a contract modification
Manages clinical management resource levels including allocation to projects, hiring and promoting, as appropriate. Participates in resource calls and ensure teams are provided with adequate levels of appropriately qualified resources
Inducts new team members to Ora where appropriate. Provides performance appraisals, evaluate and allocate bonuses and merit increases, as appropriate. Develops and motivates through goal setting, ongoing feedback, formal evaluation, and effective delegation of decision making. Ensures staff is trained and mentored according to company policies and procedures. Develops, implements and reviews key performance metrics.
Develops a human capital plan to drive a profitable P&L of the department as well as ensure the employees are engaged as Ora’s most important asset. This includes creative strategies for onboarding, retention of staff, and career progression.
Manages the overall budgeting activity of the assigned group - annual and long range forecast, project specific proposals and budgets, and investment areas as warranted
Participates in global and/or cross-functional initiatives and process improvement projects
Manages partnerships with third party vendors, customers, and key research sites.
Partner with the Head of Site and Patient Networks and SVP of Clinical Infrastructure on a site relationship and engagement program that encompasses best in class strategies for site management as well as feedback
Education and Experience:
Bachelor's Degree in a life science related field or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities. In some cases, an equivalent combination of education, professional training and experience that provides the required knowledge, skills and abilities may be considered.
Significant clinical research experience (comparable to 15+ years) including remote and clinical monitoring and experience in all phases of study life cycle, including start up, interim and close out.
Line management experience appropriate to the size and complexity of the clinical management group in the designated country/region. Valid Driver's License and Passport.