Director, Clinical Operations

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.

Job Title: Director, Clinical Operations

Location: Remote, US

Function: Clinical Operations

DESCRIPTION:

Director, Clinical Operations is responsible for oversight and management of regional (NA) and global Clinical Development activities to ensure quality and timely performance of all investigational site activities and study file management for Clinical Studies conducted by Sitero. The Director will be responsible for building a high-performing regional Clinical Operations Team in NA, and for the technical leadership and successful execution of projects in accordance with regulatory, ICH-GCP, Company and Sponsor requirements.

In addition, this individual will be responsible for the Identification, Operational Assessment, Selection and Operational Oversight of Vendors in the NA region. This individual will be responsible for the development and delivery of required operational trainings to support the team regionally and globally.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Ensures that the Company’s internal procedures are followed and are not in conflict with local legislation.
• Evaluate and determine regional clinical operational trial resources and resource strategies, including evaluation of staffing needs for trial management, personnel requisitions, hiring and assignments.
• Lead and participate in the selection and on boarding process for new staff by conducting candidate review and participating in the interviewing process.
• Attract, retain and foster individual development of key personnel for continued success in current and future assignments by providing resources and opportunity for appropriate training, mentoring or other experiences.
• Lead and motivate employees, provide feedback, coaching and counselling to enhance or improve performance by setting expectations and holding individuals accountable for performance and behavior.
• Review Business Development activities within the region and support Requests For Information and Proposals, direct regional feasibility and country selections, review bids and communicate potential projects to other Clinical Operations Stakeholders to ensure adequate resources are in place.
• Provide strategic planning and site selection, negotiations and patient recruitment planning, including review of project specific metrics to ensure regional projects are managed and investigators and sites are well supported.
• Liaise regularly with all departments working closely to ensure Project Management Department deliverables are consistently met for all projects and are appropriately conducted by attending Project meetings.
• Provide oversight and support to study team leaders and managers through coaching, mentoring, supervising, and developing/training.
• Manage the quality of assigned staff’s work through regular review and evaluation of work product. Ensure that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by management.
• Identify quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
• Maintain current knowledge of and ensure all team activities arising or occurring within the designated region are conducted in compliance with the full range of related internal and external systems, technology, regulatory requirements and related policies and procedures.
• Advocate potential process improvements. Lead the establishment and implementation of best practices and continuous improvement in collaboration throughout the organization. Ensure consistent communication and distribution of information and relevant process changes including updates to training curriculum in collaboration with QA team.
• Author, review and revise Standard Operating Procedures applicable for Clinical Operations Staff.
• Effectively communicate with and influence individuals at all levels of the organization. Serve as a key conduit in effectively communicating organizational information through the departments.
• Work towards identification of suitable vendors for operational needs in the APAC region in consultation with Executive Management.
• Perform a thorough Operational Assessment and Selection of suitable Vendors in the APAC region depending on organizational and project needs.
• Support QA with coordination for vendor qualification audits, as needed in APAC.
• Provide Operational oversight to APAC vendors and their assigned resources to ensure they have been appropriately onboarded, relevant access provided, relevant operational SOPs, Policies and other trainings have been assigned to them.
• Oversee training compliance for Clinical Operations resources in the region.
• Coordinate with Vendor’s QA team for CAPA responses to Audit findings and ensure completion of data entry in the CAPA Management System.
• Manage any other additional responsibilities as assigned.

EDUCATION AND EXPERIENCE REQUIRED:

• 10 plus years of experience in Clinical Operations.
• Life Science Graduate with master’s preferred.

PREFERRED SKILLS:

• Advanced knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
• Strong written and verbal communication skills. English fluent.
• Effective communication, organizational, and interpersonal skills.
• Excellent knowledge of clinical trial structures and organizations.
• Effective time management. Ability to develop, organize and manage multiple tasks.
• Ability to deal with competing priorities. Strong reasoning and creative problem-solving skills.
• Strong leadership and management skills.
• Excellent decision making and presentation skills.
• Ability to work independently.
• Proficient in the use of computer and software systems including use of Microsoft Word, Excel and PowerPoint.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients.
• Ability to travel as required both locally and internationally.

COMPENSATION & BENEFITS:

Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.

EMPLOYMENT TYPE:

Full Time, Permanent

COMMITMENTS:

• Standard Hours 40 hours per week, one hour lunch, Monday – Friday. Additional hours as needed.
• Willing to work in shifts as and when needed.

DISCLAIMER:

Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.