Director Clinical Operations

Remote Director Clinical Operations– Perm - $250,000 - $275,000
The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

An American Company is seeking a Remote Director Clinical Operations

Role Description

Must be in NY/NJ or PA (Northeast second preference)

• Acts as active member of Clinical Operations leadership team
• Evaluates Clinical Operations resources needs to achieve the goals
• Maintains Clinical Operations staff by selecting, recruiting, integrating and managing staff member
• Serves as supervisor, resource, mentor, trainer and motivator to team members
• Establishes and communicates team job expectations and guidelines
• Performs competency and performance assessments across her/his team and implements and monitors
development plans with direct reports.
• In collaboration with the Head of Clinical Operations, assists in the development of strategic plans for
operational activities, implements and manages operational plans, provide appropriate reporting to senior
management
• Leads the development of the operational strategy
• Defines and oversees study timelines, milestones and scope
• Ensures overall study budget assessment, planning and management. Ensures on a regular basis that budget
and invoicing are accurate.
• Coordinates vendors’ identification, qualification and selection.
• Oversees service agreements and budgets negotiation with vendors. Ensures contracting processes are
completed in accordance with study timelines, budget and scope. Oversees adherence to project budget and
contracts and assists in the identification and development of change order.
• Ensures consistent, efficient and effective communication with and between vendors
• Ensures proper supervision of performance for all services delegated to vendors, including escalation of
issues to senior management, where appropriate.
• Oversees, leads and manages the study cross‐functional team (including regulatory, clinical operations,
medical monitoring, safety, data management, biostatistics, medical writing and any consultant) to conduct
the clinical study on time, on budget and of highest quality.
• Oversees study delivery and ensures quality of deliverables by reviewing/approving some key documents
such as protocol, study plans (e.g. Project Management Plan, Risk Management Plan, Data Management,
Safety Management Plan…) or Clinical Study Report
• Identifies critical project success factors. Ensures assessment, management and documentation of
potential project risks including probability and impact. Ensures risk mitigation strategy and actions are
defined, implemented and followed.
• Proactively monitors the study progress and performance and ensures escalation of major risks and
operational quality issues as well as development of associated CAPAs.
• Provides updates regarding study progress and performance, risk assessment, timelines and financial metrics
on a regular basis to senior management.
• Contributes to team effort and provides technical support where required
• Contributes to audit plan implementation and update. In collaboration with Quality Assurance team,
ensures compliance to the audit plan
• Prepares and oversees study audits/inspections both internal and external, including CAPA implementation
and follow‐up
• Ensures the study “audit/inspection ready” at all times
• Serves as subject matter expert in audits, as well as in regulatory inspections

Skills & Requirements

• Expert knowledge of clinical research, including strong knowledge of applicable standards such as clinical
trial regulations and guidelines, GCP‐ICH guidelines
• Expertise in clinical operations
• Expertise in project management
• Excellent leadership skills, decision making
• Excellent organizational and problem-solving skills
• Excellent planning skills, analytical mind, strong sense of priorities
• Ability to adapt to a rapidly changing work environment
• Strong organizational and planning skills, analytical mind, strong sense of priorities
• Team management and collaborative capabilities

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is an Equal Opportunity Employer including disability/veteran.

In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570

Drug testing may be required; please contact a recruiter for more information. #1142765

Summary

Job Type
Permanent
Industry
Technology & Internet Services
Location
Remote
Specialism
Projects & Change Management
Pay
250,000 - 275,000
Ref:
1142765