CRA Manager ()

Beschrijving:

Looking for a Clinical Research Associate Manager Reports to the Clinical Director As a Clinical Research Associate Manager,you will

• Recruit, evaluate and develop Clinical Research Associates (CRA) Clinical Projects Administrators (CPA).
• Support development and implement the clinical strategy.
• Ensure that CRA and CPA support the project teams where needed to ensure data quality and compliance of designated clinical projects with Project Plan and applicable Standards and Regulations.
• Ensure CRAs CPAs work with the highest standard of quality defined by Company Standard operating Procedures (SOPs) and by Good Clinical Practice.
• Contribute to the development and implementation of monitoring tools and processes in cooperation with ID Shared Services.
• Participate to the promotion of SJM professional image as a clinical and scientific company.

ROLES RESPONSIBILITIES People management:

Identify and recruit CRAs CPAs to fill open positions, as per the departmental needs

Evaluate team members on an ongoing basis, and perform appraisals to assess training and development needs and to address people development opportunities. Clinical strategy:

Support development (incl. resources estimations/allocation) and implement clinical strategy

Support EMEA wide CRA CPA alignment with Company Standard operating Procedures (SOPs) and by Good Clinical Practice

Perform Co-Monitoring visits with all CRAs within EMEA

Organise CRA conference calls CRA meetings

Maintain up-to-date quality and regulatory knowledge related to clinical activities (e.g. Data Protection, GCP, etc.)

Maintain share knowledge on monitoring practice Clinical projects:

Ensure that clinical projects receive CRA CPA support where needed to ensure data quality of designated clinical projects, in compliance with SJM SOPs, international guidelines, and local legal and regulatory requirements.

Ensure CRAs and CPAs participate actively in the cross-functional Projects Teams Clinical processes:

Cooperate with other Managers and with ID Biometrics to improve processes and tools for better project executing and reporting

Suggest idea’s for quality improvement overall Willing to travel (approx 25% on average)

Qualifications:

• Medical/biomedical background (RN/Engineer/PhD/MD, etc.) or relevant previous experience.

Knowledge and skills:

Fluency in English. Any other local or European language is an asset.

Proficiency in MS Outlook, Word, Excel and PowerPoint.

• Contract of indefinite duration

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