Careers

Careers

At Accord Research we are always looking for talented professionals to join our team. We have a dynamic, young and friendly team and we offer interesting working opportunities in exciting scientific fields, alongside competitive salaries and conditions. At Accord Research your career ambitions can become a reality.

If you are interested in working with us please send us your CV and cover letter HERE.

For any other inquiries contact us on hr@accord-research.com

Senior Clinical Trial Administrator

Position Summary

To assist the Project team (PDs/PM/CRA) in ensuring the most effective and efficient conduct of clinical studies phase I.-IV. by providing administration and project tracking support.

Key Activities and Responsibilities

  • To provide general administrative support and assistance to the Project team
  • To have thorough understanding of the Clinical Research Process
  • To have thorough working knowledge and understanding with ICH GCP, appropriate regulations, relevant Accord research SOP’s
  • Submission of clinical trials to Ethics /Regulatory with cooperation with CRAs
  • To be responsible for setting up, organizing and maintaining clinical study documentation (e.g. Study Files, etc.)
  • To process collection study documentation, tracking, quality control as appropriate for the study.
  • To assist in quality control audits of clinical study documentation (e.g. Study Files, etc.).
  • To ensure that any clinical trial databases/ tracking tools are set up and maintained throughout the study.
  • To coordinate archiving of study documentation
  • To copy and route incoming study correspondence, internal documentation, CRFs, etc., as appropriate.
  • To co-ordinate ordering/dispatch and tracking of study as appropriate
  • To assist in co-ordination of investigator payments and other invoices, if applicable.
  • To contact clinical sites for specific requests (e.g., missing documentation, laboratory and equipment certification, meeting arrangements, etc.).
  • To attend Project Team meetings and generate meeting minutes
  • To assist in the production of slides, overheads, etc., as needed for project, departmental presentations
  • Participation at site visit with CRA to provide administrative support to CRA
  • Reads, understands, signs and follow assigned SOPs, Manuals, Policies
  • Other duties as assigned

Competences, Skills and Qualification

  • 1 year experience of CTA position
  • Diploma Secondary Education or equivalent
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily
  • Abundant and relevant work experience within the industry required with all appropriate skill sets to perform as Assistant for multiple clinical studies/programs
  • Research or Health Care related academic or work experience preferable
  • Excellent organizational skills, ability to manage multiple tasks and meticulous attention to detail
  • Excellent written and verbal communication skills; able to liaise successfully with all levels of management
  • Good written and spoken English
  • Excellent Computer literacy: e.g. Microsoft Word, Excel, PowerPoint, Outlook.
  • Willingness to travel for job related activities if required (expected travel for this position is < 10%)

Apply Mám zájem

Project Director (Clinical Project Management)

Position Summary

  • Direct, supervise and manage assigned trial or multi-trial project(s) within the allocated therapeutic field, ensuring quality deliverables on time and within budget.
  • Ensure that all project work is completed in accordance with controlled documents, policies, approved project specific plans and practices.
  • Manage staff in accordance with Accord Research policies and applicable regulations.

Key activities and Responsibilities

  • Direct, supervise and manage the scope of work, objectives, timelines, quality of deliverables, and all other project management activities for the trial or multi-trial project(s)
  • Serve as oversight contact with vendors to ensure appropriate communication channels are maintained and reporting schedules adhered to.
  • Direct, supervise and manage project plans development for all phases of the project lifecycle
  • Direct, supervise and manage project budget(s) to meet financial and company goals
  • Supervise maintenance of project management information and tracking systems
  • Evaluate probability and their impact of risks, develop and implement quality and risk management plans for minimizing impact on project objectives and deliverables
  • Continually review and ensure adequate resources are available to meet project deliverables and milestones
  • Develop and implement continuous improvement processes for assigned trial or multi-trial project(s)
  • Line Manager Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems
  • Coach and mentor employees around project planning, project review, risk management and problem solving to ensure global alignment of work practices across the team through the adoption and use of all process and technology tools and improvements by employees
  • Obtain and provide regular feedback to employees from other project team members and key stakeholders to assist in personal and professional development. May attend site visits in order to support development needs. 
  • Identify skill and competency gaps at the individual level and work to craft appropriate development plans.

Competences, Skills and Qualification

  • MS degree in Science/Health discipline
  • Excellent communication and interpersonal skills, including good command of English language
  • Demonstrated ability to deliver results to the appropriate quality and timeline metrics
  • In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines 
  • In depth therapeutic and protocol knowledge
  • Strong organizational and problem solving skills
  • Strong influencing and negotiation skills
  • Good team leadership skills
  • Effective mentoring and training skills
  • Good judgment
  • Effective presentation skills
  • Ability to manage competing priorities
  • Strong software and computer skills, including MS Office applications
  • Ability to establish and maintain effective working relationships with coworkers, managers and Vendors
  • Working knowledge of assigned therapeutic area

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Project Manager (Clinical Project Management)

Position summary

  • Responsible for successful conduct of assigned clinical projects
  • Serves as the Project Lead for key business development opportunities
  • Responsible for establishing working relationships with client project teams to ensure client satisfaction and operational excellence
  • Defines and manages project resource needs 
  • Responsible for development of management plans and tools for assigned projects
  • Issue identification and problem solving

Key activities and responsibilities

  • Managing the day-to-day activities necessary for the successful completion of a project within Accord Research and client timelines and budget
  • Serving as the Project Lead for key business development opportunities, including the preparation and delivery of client presentations
  • Responsible for establishing excellent working relationships with client project teams to ensure client satisfaction and operational excellence
  • Defining and managing project resource needs to ensure on-time and on-budget deliverables for assigned projects
  • Providing ongoing leadership and performance feedback to project team members
  • Managing preparation of the study budget and site contract negotiations,
  • Identifying, contacting and managing external vendors if required for a successful  study conduct
  • Responsible for ensuring the successful design, implementation, tracking and revisions of project plans
  • Managing all aspects of a clinical study and accountable for timelines, budgets, and quality
  • Supporting project team, assisting in study-specific training and providing regular feedback to line managers on staff performance
  • Ensuring the protection of study subjects and managing adverse events reporting and follow up

Competences, Skills and Qualification

  • University/College degree (life science preferred) or certification in a related allied health profession (e.g. nursing certification, medical or laboratory technology)
  • Minimum 5 years clinical research experience in a pharmaceutical company or CRO
  • Demonstrated ability to inspire effective teamwork and motivate staff within a matrix environment
  • Excellent written and oral communication skills
  • Ability to work under pressure within fixed deadlines and  to handle multiple competing priorities
  • Analytical, interpersonal, negotiation skills
  • Financial awareness and ability to actively manage financial tracking systems
  • Advanced planning, organizational and problem solving skills to meet client expectations
  • Proactive and able to work with little or no supervision
  • Understanding of statistical programming, data management, and clinical trial report preparation processes
  • Excellent knowledge of drug development process,  ICH/GCP guidelines and ability to lead a clinical project team
  • Fluent in written and verbal English
  • Advanced computer competency

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Associate Clinical Data Manager

Position Summary

  • The Associate Clinical Data Manager serves as a Data Management contact with sponsors and represents the department in the different project teams. 
  • He/she is responsible for ensuring clinical study databases are build, tested and validated, data cleaning activities are performed on an ongoing basis from study initiation through database lock, and data is archived.
  • The Associate Data Manager supports in coordinating the receipt and processing of all study related data including data from external service providers and provides overall status updates to the relevant project team.
  • In addition, it is his/her responsibility to ensure the Data Management processes and systems used during the life time of a study are properly documented and comply with regulatory requirements. 

Key Activities and Responsibilities

  • Provide input in study set-up and initiation procedures such as eCRF design, database design, edit check design/review/UAT, and related Data Management documents.
  • Ensure the proper collection, management, and storage of clinical trial data (according to regulatory requirements).
  • Supports proper clinical data validation, review and query management.
  • Performs activities to complete project deliverables on schedule according to quality standards, from study start-up through archival.
  • Supports receipt and handling of data received from external service providers and directs reconciliation where applicable.
  • Maintains open communication with internal and external customers by contacting project team members on agreed-upon schedule, responding to correspondence promptly and within agreed timeframes and choosing method of communication based on urgency and type of information being communicated.
  • Demonstrate positive working relationship with internal customers and sponsor by keeping them up to date about progress of projects and working with them to develop coordinated plans that meet customers’ needs.
  • Maintains current study documentation and which accurately reflect process deviations and changes in project assumptions.
  • Provides input in evaluating project team requests by considering factors such as efficiency, quality, data integrity, resources, and customer relations before committing to an action; seeks out existing knowledge prior to developing new methods. Reach out to head of Data Management as appropriate.
  • Develops and maintains Data Management study files. Specifies data cleaning guidelines, conventions, Standard Operating Procedure (GSOP), data workflow, and other processes, which will be followed to meet sponsor requirements.
  • Prepares in advance for internal and external meetings, completes action items within required timeframe, and attends internal meetings regularly, providing input, and demonstrating respect for opinions of others.
  • As a key member of the Data Management department, provides input  in defining processes, procedures related to operational effectiveness of the used Clinical Data Management Systems

Competences, Skills and Qualification

  • Bachelor’s degree in medical, scientific, biological, statistical, computer science, or related field or equivalent experience
  • Have experience/recent exposure to pharma/biotech industry
  • Have Experience in planning, setup, conduct and reporting of different stage clinical trials
  • Practical expertise in most aspects of Data Management
  • Client communication and reporting experience
  • Expertise in translating protocol requirements into eCRF design
  • Experience with EDC systems, understanding of relational Databases
  • Exposed to standardized CRFs libraries
  • Basic knowledge of CDISC-SDTM data standardization specifications
  • Experienced in all Data Management aspects like query management, document creation and review, etc…
  • Understanding / knowledge of the drug development and clinical research process
  • Familiarity with ICH GCP as well as general knowledge of industry practices and standards
  • Good cooperation skills with clients and other departments’ representatives
  • Demonstrating pro-active and independent delivery of tasks
  • Proficiency with Microsoft Office (Excel, Word, PowerPoint, and Outlook)
  • Good verbal and written communication skills and English fluency

Apply Mám zájem