CLINICAL OPERATIONS ASSOCIATE

15/10/21

Location

Industriepark Zwijnaarde 7C, Zwijnaarde, Belgium

Function type

contract of indefinite duration

Vacancy

Precigen ActoBio is seeking a Clinical Operations Associate to play a key role in the Clinical Operations Team. This position will be primarily responsible to support the clinical team with the planning and execution of clinical studies of our unique drug delivery platform across a number of different indications.

 

DUTIES AND RESPONSIBILITIES:

  • Support clinical trials vendor management and oversight by performing assigned clinical operations tasks from study start-up through study execution and closeout

  • Contribute to both internal study team meetings and vendor meetings by providing study updates and writing meeting minutes

  • Assist in the planning and execution of Investigator Meetings

  • Assist in the development and Quality Control (QC) of vendor-related scopes of work, site tools, web-based applications, instruction manuals, and identify updates as needed during study conduct

  • Assist with Trial Master File (TMF) submissions

  • Establish collaborative relationships with colleagues in Clinical Development, Clinical Supplies, Regulatory Affairs, Quality Assurance and throughout the Company

  • Develop and maintain tracking tools for clinical trials

  • Support development and QC check of study-related documents including site feasibility, TMF, informed consent documents (site specific), monitoring plans, regulatory and start-up plans, patient recruitment plans, pharmacy and lab manuals and training materials, clinical study reports

  • Support in the clinical Quality Management System:

    • Assist in writing deviations, investigations, CAPA, Change Controls in close cooperation with the clinical and QA team

    • Writing and review of clinical SOPs

    • Guarantee good documentation practices

    • You contribute to guaranteeing the clinical quality level and you work on continuous (quality)improvement

    • You are responsible for encouraging employees to respect the GCP rules

  • Work collaboratively with supply chain to ensure seamless coordination of investigational medicinal product (IMP).

  • Identify issues, recommend and follow up on corrective actions to ensure quick resolution of deviations or quality issues

  • Participate in the development, review and implementation of departmental SOPs and processes

  • Perform additional tasks and duties as assigned

 

EDUCATION AND EXPERIENCE:

  • Bachelor’s or master’s degree, or equivalent, in a biomedical, life science, or related field of study. Equivalent combination of education and applicable job experience may be considered

  • Minimum 3-5 years of clinical operations experience in a biotech/pharmaceutical or CRO setting or related work experience

  •  Good knowledge of applicable GCPs, ICH guidelines and FDA/EMA regulations

  • Experience with quality and quality control processes within clinical operations

  • Proactive, self-starter who possesses exceptional multi-tasking and communication skills, both oral and written

  • Strong computer proficiency and software experience particularly with Microsoft Office applications

  • Good problem solving skills, a strong sense of urgency, keen attention to detail, ability to work independently as well as functioning as a team player

  • Ability to contribute technical expertise to the various aspects of the clinical trial process

DESIRED KEY COMPETENCIES:

  • Ability to understand and execute the company’s mission and values

  • Value-based collaborator – respectful, accountable and collaborative

  • Impactful written and verbal English communication skills

  • Ability to build working relations throughout the organization to achieve business goals

  • Strong time management and organizational skills

  • You are results-oriented and decisive

  • You are persuasive and cooperative

  • Knowledge of early and ideally late-stage clinical trial management

  • Knowledge of clinical Quality Management Systems is a requirement (GCP)

  • Experience with inflammatory and/or autoimmunity disease trials

  • Appreciation of diversity and multiculturalism

 

Precigen ActoBio™ is a clinical stage biotechnology company pioneering a new class of therapeutic agents created on the ActoBiotics™ platform. These are targeted, microbe-based, specifically designed agents that express and locally deliver potential disease-modifying therapeutics at disease sites including the intestine, the mouth and the nasopharynx, to treat a range of disorders. We have a strong R&D pipeline and an extensive portfolio of candidates advancing toward clinical development across a number of potential indications.

Precigen ActoBio™ is a wholly-owned subsidiary of Precigen. (Nasdaq: PGEN)

We invite you to discover more at Precigen ActoBio.

 

Recruiting Contact: Inge Vandenhove: abt.jobs@actobio.com  

 

 

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