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Responsible for the line management, selection, training, coaching and performance management of Clinical Research Associates, Project Assistants and Remote Site Monitors. Focusing on end results to be achieved, uses metrics and key performance indicators to manage individual and team performance. This position forms a key role within local Country Management and will report to the Country Head.

Primary Accountabilities

30% - Provides mentorship, work direction and coaching of CRAs through activities such as accompanied field visits, file review and visit report reviews. Maintains records of Accompanied Field Visits and certification of individuals monitoring proficiency and ensures required AFV frequency is achieved.

20% - Interviews, recruits and selects staff. Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company.

10% - Allocates staff to projects through local resourcing process. Supports activities of Project Managers and Clinical Team Managers to optimize the operational running of projects.

10% - Ensures all staff CVs, training records, position profiles and experience profiles are complete and up to date. Ensures timeliness and accuracy of timesheets and expense reports.

10% - Delivers training on SOPs, WPDs local requirements and any other subjects that impact on clinical operations. Identify training gaps, ensure that training requirements are met. May develop local WPDs where required in conjunction with training department or senior management. May contribute to development of training programs, where appropriate.

10% - Conduct regular performance appraisals and career discussions with staff. Facilitates employee career development through encouraging participation in professional meetings and career development programs.

5% - Alert management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required.

5% - Conduct feasibility studies, provide input into bids and contribute to the procurement of new business where required.

Education and Experience: 

  • Bachelor’s Degree in Health Sciences
  • Significant clinical research experience (comparable to 4 years) including clinical monitoring and experience in all phases of study life cycle, including start up, interim and close out
  • Line management experience appropriate to the size and complexity of the clinical management group in the designated country/region
  • Valid Driver’s License
  • Valid Passport

Knowledge, Skills and Abilities:

  • Demonstrate effective mentoring/leadership/supervisory ability including excellent interpersonal skills.
  • Excellent clinical trials monitoring skills.
  • Demonstrate understanding of or ability to learn and demonstrate understanding of PPD SOPs, WPDs, and relevant regulations e.g. ICH/GCP, FDA guidelines).
  • Demonstrate ability to evaluate medical research data and demonstrate proficient knowledge of medical terminology.
  • Effective organizational and negotiation skills.
  • Strong attention to detail.
  • Effective written and oral communication skills.
  • Good knowledge of English language and grammar.
  • Competent use of computer to include data entry, archival and retrieval.
  • Ability to travel as needed.
  • Excellent team player with team building skills.
  • Excellent interpersonal and conflict resolution skills.
  • Utilize problem-solving techniques applicable to constantly changing environment.
  • Proficient knowledge of medical/therapeutic areas and medical terminology.

This position is office based in Copenhagen. We look forward to receiving your application.

Jobannoncen leveres i samarbejde med StepStone.

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Bankdata
JKS a/s
DLG
Danfoss
DEDIKATION ApS
SDC
Sydbank
HOFOR
Solar
House of Prince (BAT)
People & Performance
Moment