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Director, Research Operations (Remote)

Job Title
Director, Research Operations (Remote)
Job ID
27477090
Work From Home
Yes
Location
Austin,  TX 78738
Other Location
Description

JOB SUMMARY 

 

The Director of Research Operations (DRO) is a senior member of the Research Operations team with process and personnel responsibilities. He/she will direct and oversee the study management team and work in collaboration with the Research Operations Program Management leaders to ensure successful conduct of clinical trials at Elligo clinics. 

 

He/she will be responsible for appropriately resourcing and managing clinical studies to ensure they are delivered efficiently to timeline, budget and quality expectations. The DRO will provide study management expertise across the organization and be a key contributor to the strategic and functional objectives of the department.

 

The DRO, working closely with management peers to develop, implement and maintain processes and performance standards that ensure consistent and high quality conduct of clinical trials across physically separate clinics across multiple provinces to achieve study objectives and corporate goals, including the following specified tasks:

 

  • Leader and manage Research Operations personnel, including contract and partner company staff when required.
  • Allocate operational staff to projects/clinics in accordance with agreed upon priorities and in collaboration with other members of Elligo management.
  • Develop and refine staff training, processes (SOPs, and technology systems requirements, training & implementation to streamline efficiency, consistency and scalability of Elligo operations.
  • Ensure operations staff members and supporting partner staff are appropriately trainedand led .Monitor, control and report team achievement of corporate, client and expectations.
  • Collaborate with management peers to promote the desired Elligo profile with clinics during all stages of engagement.
  • Collaborate with management peers to ensure agreed deliverables are achieved on time, and monitoring budget and key performance indicators.
  • Provide input to proposals for project bids to ensure projects can be managed within agreed upon schedules and objectives achieved
  • Provide recommendations on executional aspects of research operations, including risk identification and mitigation, to manage study or clinic nuances.
  • Ensure or conduct review of staff study conduct performance through documentation or metrics review (e.g. CTMS entry) and performance of field quality control visits.
  • Ensure operational excellence and integrity through adherence with Elligo policies and procedures, client requirements, ICH GCP, , Health Canada, EMA and other relevant regulatory requirements.
  • Monitor, control and report department budget expenditures, as required.

 

Qualifications and Education Requirements

 

  • BS/BA in Life Science or related discipline
  • Previous nursing or management experience in a clinical setting preferred
  • Well versed and current in ICH GCP, FDA, Health Canada, EMA and other relevant regulations and guidances that govern clinical trial conduct
  • 10+ year’s pharmaceutical/biotechnology experience in drug development.
  • Previous supervisory experience required, and supervisory experience of remotely based staff preferred
  • Proven track record building and managing teams; able to coach, mentor and provide career development guidance to staff
  • Able to marshal resources and inspire teams to achieve collaborative goals
  • Demonstrated ability in positive relationship building, with strong verbal and written skills required
  • Strong interpersonal skills with attention to detail
  • Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with clinical trial management systems
  • Ability to travel for recruitment, clinic visits, staff QC activities, team meetings, conferences or client meetings, as required

 

WORKING CONDITIONS

 

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.

 

Some flexibility in hours is allowed, but the employee must be available during the “core” work hours of 9:30 a.m. to 3:30 p.m. and must work 37.5 hours each week to maintain full-time status. Occasional evening and weekend work may be required as job duties demand.

 

Regular travel (25-50%) travel is required for this position.

 

The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position.   They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel.  More in-depth information can be found in SOP's, working guidelines, policies, etc.

 

Elligo is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Elligo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Elligo will not tolerate discrimination or harassment based on any of these characteristics. In addition, Elligo will provide reasonable accommodations for qualified individuals with disabilities.

 

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“I am super passionate about what we are doing at Elligo and feel so fortunate to be a part of it! I haven’t been this excited about a job in years!”

Janet L.
Client Relations Specialist

“Having been involved in clinical research for over 10 years, I have found the Elligo model to be truly innovative. From top to bottom, the Elligo team is made up of professionals who use their experience and knowledge to positively affect the need to bring healthcare and clinical research together.”

James C.
Director, Clinical Operations

“Elligo is at the forefront of innovation in the clinical research industry. It’s rewarding to work among such highly motivated and distinguished leaders and visionaries. I start work each day feeling valued and end each day excited to be part of Elligo’s influence on changing the clinical research industry.”

Julie M.
Study Manager, Clinical Operations

“Working at Elligo has been a very unique experience. I love the fact that I’m surrounded by colleagues who help me learn something new every day. I value their experience and genuinely enjoy the work and projects we are involved with. I love coming to work every day!”

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Business Analyst, Business Development

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