Clinical Operations Associate

Job Title:

Clinical Operations Associate – Level 2

Department:

Clinical Operations

Compensation:

• Salary:
  TBD

PKR per month
- Benefits: This position offers a competitive salary designed to provide employees the flexibility to arrange benefits according to their individual needs and preferences. Where applicable and available, company-sponsored benefits may also be offered.

Work Location, Hours and Flexibility:

• Location:
• In-office: Islamabad or Peshawar, Pakistan

Note: Work location is subject to change based on evolving organizational needs.

·      Work Hours and Global Alignment:

• Standard work hours will vary by role and location and may not follow a traditional 9:00 AM – 5:00 PM schedule. This role requires
  availability Monday through Friday
  , with
  at least 5–6 hours of daily overlap with the U.S.-based leadership team
  , particularly in the initial phase. Candidates must be able to align working hours across
  Pakistan and U.S. time zones
  to participate in key meetings and complete time-sensitive tasks.
• Flexibility Expectations:
• Flexibility is essential, as meetings and collaboration with international colleagues may occasionally occur outside of typical business hours. The schedule may evolve over time depending on team needs and the individual's demonstrated ability to work independently. Participation in both scheduled and ad hoc meetings, sometimes on short notice, across time zones and outside of regular work hours, is expected
• Global Collaboration:
• This role involves regular interaction with colleagues and clients across multiple countries and time zones. Candidates must be comfortable operating in a globally distributed, international team environment.

Employment Type
:

Full-Time

Position Summary:

We are seeking a detail-oriented and technically adept Clinical Operations Associate with specialized expertise in clinical systems and certification processes. This role blends core project coordination with hands-on involvement in the design, development, and operation of digital data capture and certification systems, particularly within the ophthalmology domain.

The ideal candidate will have a strong background in clinical research operations, with the technical acumen to troubleshoot system issues, recommend enhancements, and ensure timely completion of certification requirements for clinical sites. This position is critical in bridging operational project needs with system functionality, ensuring both compliance and efficiency across diverse clinical research activities.

Key Responsibilities:

1. Clinical Systems, Certification, and Operational Support:

·      Support the design, development, testing, and operation of digital data capture systems (DDCS) tailored to clinical research needs, as well as certification systems in the ophthalmology domain.

·      Provide assistance to site staff in meeting certification requirements, ensuring timely completion and compliance.

·      Address technical queries and troubleshoot issues related to certification systems in collaboration with developers.

·      Maintain accurate records of certification operations and ensure staff have up-to-date status information.

·      Assist in creating and maintaining Standard Operating Procedures (SOPs) for system validation and project-specific requirements.

·      Recommend system enhancements and new features based on user experience and evolving project needs.

·      Participate in the development of trial-related documents, including protocols, informed consent forms (ICFs), and case report forms (CRFs), in collaboration with clinical science teams.

·      Maintain effective cross-functional communication across time zones to ensure smooth coordination of tasks.

·      Complete all required organizational and regulatory trainings in accordance with guidelines and SOPs.

2.
Project Management:

• Lead the management efforts for assigned clinical research projects.
• Draft and assist in designing project workflows and charters.
• Coordinate the building and setup of projects on CREST systems.
• Develop and maintain project schedules, set targets, establish measurements, and ensure accountabilities.
• Lead both internal and client/external team meetings, prepare agendas, and approve meeting minutes.

3.Team Leadership (for leadership positions only):

• Supervise and provide guidance to CRAs/PMs to ensure team efficiency.
• Assist with recruitment efforts for the Clinical Operations team.
• Develop training modules and courses for CRAs/PMs.
• Oversee and administer training for CRAs/PMs.
• Formally supervise, train, and mentor junior staff or students, which may include hiring, conducting performance evaluations, and providing project work instruction.

4.Clinical Research:

• Conduct clinical research and independently manage progressively more complex projects and assignments.
• Oversee significant aspects of large studies or manage all aspects of smaller research studies conducted across multiple sites.
• Manage data for research projects, including developing systems for organizing, collecting, reporting, and monitoring data.

5.Compliance and Quality Assurance:

• Adhere to all organizational policies and procedures.
• Ensure audit preparedness and operations compliance with applicable regulations.
• Lead efforts to identify and implement corrective actions and processes.
• Regularly inspect study documents to ensure regulatory compliance.

6. Communication and Collaboration

• Attend all relevant meetings, including those with sponsor clients, vendors, and contractors.
• Be available for emergency calls during off-hours as needed.
• Provide leadership in identifying, recommending, and implementing improvements to policies and processes, and define best practices.
• Collaborate with cross-functional teams and be adaptable to take on multiple roles as needed.

7. Financial Management:

• Track study-specific milestones and invoice sponsors in accordance with study contracts.

8. Performance Evaluation:

• Assist in appraising and regularly reviewing the performance of the Clinical Operations team.

9. Continuing Education and Knowledge Sharing:

• Participate in continuing education courses and training.
• Prepare presentations on journal and scholarly articles.
• Attend conferences virtually and share lessons learned.
• Actively collaborate and contribute to knowledge sharing within the team.

Qualifications:

Education:

·      Advanced degree (e.g., PhD, MD, DrPH, OD, PharmD, MPH, MBBS*, or equivalent) in Public Health, Biomedical Sciences, Clinical Sciences, Data Science, Business Administration, or a related field.

·      A Master's or Bachelor's degree may be considered with substantial equivalent professional experience and specialized training.

·      
Note: MBBS is acceptable only if the candidate does not intend to pursue a clinical career.

Experience and Skills:

·     
Fluency in English
(written and spoken) is required; ability to communicate clearly with international teams and clients.

·      Demonstrated ability to manage complex projects, meet deadlines, and coordinate across multidisciplinary teams.

·      Ability to adapt to shifting priorities, work across global time zones, and handle confidential information with professionalism.

·      Experience in collaborating with cross-functional teams

·      Experience working in a fast-paced development environment

• Minimum of two years of project management experience in a healthcare setting, or equivalent relevant experience.

Key Skills:

• Effective communication and interpersonal skills with a focus on teamwork and collaboration.
• Ability to work independently and as part of a team.
• Ability to work under strict deliverable timelines and manage stressful situations.
• Skilled at working cooperatively across diverse teams and time zones to achieve shared goals.
• Effective communication and interpersonal skills.
• Strong team management abilities.
• Strong project management skills with exceptional attention to detail.
• Solid understanding of clinical research methodologies and regulatory frameworks.
• Proven ability to develop, manage, and monitor complex project timelines and budgets.
• Ability to co-perform effectively, delegate and escalate wherever needed.
• Comfortable working in fast-paced, interdisciplinary environments with evolving clinical and operational priorities.
• Excellent problem-solving skills, with the ability to translate complex technical solutions into business impact.
• Exceptional analytical and problem-solving skills with keen attention to detail.
• Effective communication and interpersonal skills, in addition to stakeholder management skills, with the ability to translate complex data into actionable insights for technical and non-technical audiences.
• Skilled at working cooperatively across diverse teams and time zones to achieve shared goals.
• Ability to work independently and under strict deliverable timelines and manage high-pressure situations professionally.
• Effective team collaboration and communication

About OIRRC:

The Ocular Imaging Research and Reading Center (OIRRC) is a leader in ophthalmic imaging and clinical trial support, specializing in innovative technologies and AI tools to advance eye care globally. Our mission is to revolutionize eye care by delivering cutting-edge imaging solutions that empower research, improve diagnoses, and enhance patient outcomes. We foster a collaborative and dynamic work environment that values innovation, diversity, and continuous learning, ensuring each team member's contribution is valued as we work together to make a meaningful impact on ophthalmology.