Assoc. Director, Research and Operations - Patient-Centered Research

ASSOCIATE DIRECTOR, RESEARCH OPERATIONS - EVIDERA

*We are looking to fill this role in N.A. as an office-based or 100% remote employee

Position Overview:

The Associate Director of Research Operations reports to the Senior Director of Research Operations within the Patient-Centered Research (PCR) team and leads PCR procedures and practices, overseeing development, implementation and improvement of processes and systems in collaboration with the key staff and operational and functional departments, including the Project Management Office.

Primary areas of responsibility for the Associate Director include ensuring PCR project quality and efficiency through general project management methods, liaising with external departments such as Quality Assurance, Vendor Management, Finance and Legal, and significantly contributing to the PCR Process Initiative. The Associate Director has no significant financial targets associated with the role.

In addition to developing and overseeing PCR procedures and practices, the Associate Director will oversee client and/or project management of complex projects as requested by PCR senior management.

Essential Duties and Responsibilities (other duties may be assigned):

Research Operations and Project Management – 60%

• Provide PCR subject matter expertise on key initiatives with Evidera QA, Regulatory and Data Privacy teams, including SOP review and development and associated tools, checklists, updates and training (final approval and/or escalation as required to the PCR Senior Director).


• Provide direction for the Quality Event Management (QEM) system including PCR event review and functional approvals, training and consulting PCR staff members on event decisions and actions, ongoing communication with the Evidera QA lead, and escalation of critical event investigations and approvals to senior management as per SOPs.


• Liaison to the Evidera Project Management Office, working closely on project management tools and processes to support compliance and ensure PCR study types and service offerings are represented.
  
• Provide support in setting the PCR Process Initiative goals, working closely with the Senior Director to establish the annual priorities, agendas and driving tasks forward to ensure that goals are met for the year.


• Oversee the Vendor Management (VM) process for PCR, working directly with QA and the Vendor Management Organization (VMO) on PCR specific vendors, new and existing. Advise PCR team on vendor selection and services, recommendations for due diligence for new vendors or services. Advise on PCR use of unique services, vendor audits and act as relationship manager for key PCR vendors, as needed.
  
• Support dissemination of PCR process information to staff using a variety of forums to include introducing new processes, and updates refresh on existing processes to support compliance.


• Represent PCR on cross-operations teams and liaison with Evidera operational departments as required for new process or system roll out (e.g., Financial, Legal or IT).


• Respond to individual staff queries regarding process, operations and functional area relationships.


• Coordination with PCR Scientific Pillars to support process and operations related initiatives to ensure quality and consistency in PCR operations.
  

Science Activities – 40% of time

• As requested by PCR management, provide high-level project management to complex or joint projects including operationalization and execution of projects, direct client interaction, and cross-functional leadership to support efficient collaboration between cross-functional areas.
  

Education, Professional Skills & Experience:

• Master’s degree in a scientific discipline, with at least 8 years’ experience in a similar role;
  
  or a Bachelor’s degree with at least 10 years’ relevant experience.


• Leadership experience in managing projects, teams and related finances (5+ years).


• PMP certification would be highly desirable.

Personal Skills & Competencies:

• Deep understanding of health outcomes research principles and familiarity with key aspects of the literature (historical and current)


• Advanced level understanding of relevant methodology and statistics


• Extensive knowledge of practical research implementation


• Well organized, superior time management and attention to detail
  
• Excellent verbal and written communication skills


• Ability to work as part of a team


• Highly responsive and proactive

Working Environment:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive and understand information & ideas with diverse groups of people in a comprehensible and reasonable manner.


• Able to work upright and stationary for typical working hours.
  
• Ability to use and learn standard office equipment and technology with proficiency.


• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
  
• May require travel.

Who we are?

Evidera is a business within Pharmaceutical Product Development, LLC (PPD) a leading global contract research organization (CRO), and is a preeminent provider of evidence-based solutions. We provide integrated scientific expertise and global operational capabilities to help clients generate the evidence needed to optimize the market access and commercial potential of products.

What we offer?

We know that if you are provided with the right support and resources needed you will thrive! Therefore, Evidera offers a great mix of compensation and benefits options to show you how valuable you are to the organization.

Some of our perks include:

• Highly competitive salary and bonus structure


• Generous benefits package, including healthcare, dental, vision and paid time off to spent with your friends and family


• Flexible working environment by offering fully remote work for most of our positions, to support work-life balance


• Clear opportunities for growth and career progression. We offer multiple Learning & Development programs, coaching and mentoring trainings, career planning and discussions to help you grow as a professional.


• Access to Employee Well-being programs and services. We value your emotional health and offer a variety of programs to support your mental healthcare.


• Collaborative working environment with focus on Diversity and Inclusion. At Evidera, we respect one another and recognize that our diversity makes our business stronger. We strive to be an inclusive organization where colleagues can be their authentic selves and grow their careers.
  
• Global exposure: Opportunity to work on multiple projects with some of the industry’s leading researchers around the globe.
  
• Smooth onboarding process with your own dedicated onboarding specialist and a working buddy to help you navigate through your first few weeks thus ensuring great start to your new role.

Our 4i Values:

Our 4i Values are critical components in accomplishing our mission. These values guide us and, ultimately, define us.

Integrity – Innovation – Intensity – Involvement

If you resonate with them and wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!*

• only shortlisted candidates will be contacted

#LI-REMOTE

#LI-PG1