About this role.
This remote Romania-based Senior Operations Specialist role supports operational excellence for study delivery in a clinical research, pharmaceutical, or biotechnology setting. The position leads process evaluation, root-cause analysis, change-management execution, risk mitigation, process documentation, KPI dashboards, and stakeholder communications. Candidates need 5–7 years of experience in operations support, process improvement, and change management, along with drug-development knowledge and familiarity with ICH-GCP guidance. The role operates with minimal oversight and requires strong English communication, training capability, attention to detail, and comfort in a fast-paced cross-functional environment.
Role DNA
A quick view of the complexity, pace, ownership and collaboration implied by the job description.
Job Complexity
4/5Pace & Pressure
4/5Autonomy Level
4/5Communication Load
5/5Salary analysis
Estimated compensation compared with the broader US market for similar roles.
Core skills
Skills and capabilities most closely associated with this opportunity.
Cover letter sample
Dear Hiring Team,
I am excited to apply for the Senior Operations Specialist role. My experience in process improvement, change management, and cross-functional operations equips me to identify root causes, implement sustainable workflows, and support measurable operational excellence in a regulated environment.
I bring a structured, collaborative approach to stakeholder communication, process documentation, KPI reporting, training, and adoption planning. I would welcome the opportunity to help Precision Medicine Group improve study-delivery processes and enable teams through practical, well-managed change.
Sincerely,
Applicant
Sample interview questions
I begin by clarifying the business outcome, mapping the current workflow with the people who perform it, and using data and root-cause methods to identify the highest-impact constraints. I then prioritize solutions by expected value, implementation effort, compliance risk, and stakeholder readiness, pilot the selected change, and track adoption and performance metrics after launch.
I would use a structured approach such as ADKAR: establish the reason for change, build stakeholder support, provide clear role-based communications and training, and reinforce the new behavior through metrics and feedback. I would also maintain a change-impact assessment, change radar, risk log, and adoption plan so resistance or gaps can be addressed early.
For clinical operations, I would define a balanced set of indicators covering timeliness, quality, compliance, throughput, and adoption. Examples could include cycle times, rework rates, training completion, deviation trends, process adherence, and stakeholder satisfaction; I would tailor dashboard views to decision-makers and review trends regularly to drive corrective actions.
I would first create a shared view of the objective, facts, constraints, and decision criteria. If disagreement continued, I would document options and trade-offs, facilitate a focused discussion, and escalate only when a timely decision was needed from the accountable leader; after the decision, I would communicate it clearly and support consistent execution.
I would assess the issue's scope, patient or compliance impact, likelihood, and urgency, then involve the appropriate subject-matter experts and leadership. I would document the risk, assign ownership, implement proportionate mitigation actions, communicate status transparently, and monitor whether the controls are effective.
Job Summary and Purpose:
The Senior Operations Specialist leverages expertise and knowledge to plan and manage initiatives and activities designed to improve the quality, efficiency and effectiveness of the delivery of studies to Sponsors. The Sr Operations Specialist develops and implements processes, change management plans, standards or operational plans with the goal of operational excellence across the business collaborating across a group of diverse stakeholders.
They will support a wide range of activities within the Business & Operational Excellence group. Specific tasks depend on the functional area, including Process improvement, support of training content and/or development and deployment of change management initiatives. This role executes functional priorities with minimal oversight.
Main Duties & Responsibilities
- Support the vision of and commitment to continuous improvement in operational excellence across all activities.
- Lead the evaluation of business processes and workflows to identify opportunities for improvement or automation under direction of a supervisor.
- Participate with stakeholders in root-cause problem-solving techniques to identify core process challenges.
- Support the development of recommendations for process improvement, leveraging subject matter experts for critical input.
- Partner with cross functional leadership to prioritize improvement opportunities and support strategic initiatives.
- Partner on the design and implementation of new business processes with organizational context and priorities in mind.
- Lead change management initiatives and support business through a communication framework assessment of impact on roles and deploy a variety of tactics to support change management effort to ensure adoption and sustainability of process changes.
- Lead internal communication to effectively update stakeholders on progress, performance, key issues, and blockers that may impact business attainment or critical program and project completion
- Identify operational risks and lead implementation of mitigation plans.
- Ensure or lead the documentation of business process.
- Work with leadership to establish key performance metrics and dashboards for monitoring operational performance.
- Provide insight into training and guidance to teams on new processes and how to identify improvement opportunities, building awareness on continual improvement initiatives
- Support standardized best practices and processes across the organization to ensure consistency and sustainability.
- Monitor, measure, and analyze the effectiveness of new initiatives and processes, making adjustments as needed.
- Monitor adoption of process, system and organizational changes to ensure long term and sustained adoption.
- Prepare and maintain tools and templates to support execution
- Schedule meetings, take notes, and track actions
- Travel as needed
Education and Experience:
Minimum:
- Bachelor’s degree or equivalent experience
- 5-7 years in change management, operations support, and process improvement experience
- Experience in CRO/pharmaceutical/biotechnology drug development or demonstrated competency in the key areas of the role
- Strong drug development experience with understanding of other functions relevant to the position.
Knowledge, Skills, and Competencies:
- Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint, Teams)
- Strong written and verbal English communication skills
- Knowledge of ICH-GCP and regulatory guidance
- Strong interpersonal and training skills
- Self-motivated and detail-oriented
- Ability to work independently and in teams
- Strong professionalism, sense of ownership and pride in quality of outputs
- Understanding of change management models (ie ADKAR) and use of change radars
- Flexible attitude with respect to work assignments and ability to thrive in a fast-paced dynamic environment
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com.
Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at myHR@precisionmedicinegrp.com so we can investigate and take appropriate action.
Annual salary information is not provided for this position. Explore salary ranges for similar roles in our Salary Directory ›
Upload your resume now
- To unlock remote work opportunities and be discovered by global employers.
This job listing has been manually reviewed by the Jobicy Trust & Safety Team for compliance with our posting guidelines, including verification of the company's legitimacy, accuracy of job details, clarity of remote work policy, and absence of misleading or fraudulent content.
