Clinical Data Management Development Specialist, Remote, Europe - Lisbon, Portugal

Role Specific trainings:
Collaborate with Subject Matter Experts and the Real World Evidence Data Management Team to develop and maintain Training Plan requirements and roles
Facilitate quarterly or annual training plan reviews
Develop training slides and material independently or with Subject Matter Experts
Plan, coordinate and communicate the training schedule for the Real World Evidence Data Management department

Perform training courses as needed and agreed with other stakeholders

Provide oversight of training delivered by other stakeholders.

Monitor effectiveness and timeliness of training

Training Content:
Set up and maintain folder on Data Management SharePoint site
Update / archive training items in alignment with Training Plan updates

Training Compliance:
Plan and support development of Compliance Reports
Provide review and / or oversight of staff onboarding training compliance
Provide review and / or oversight of monthly / quarterly training compliance data

Collaborate with Managers to ensure adherence to training compliance targets

Other Initiatives:

Participate, support or lead global initiatives to continuously improve training processes or compliance across Real World Evidence Data Management

Provide input on Data Management process improvements

Provide input on the development and implementation of a new technology or tool

Participate in focus teams, and  global or local best practice teams as relevant

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

Sound working knowledge of clinical data management procedures, ICH-GCP, applicable regulatory requirements, medical terminology and quality management processes
Knowledge of Drug Development processes
Knowledge of CRO or Pharmaceutical Industry operations

Sound knowledge of current training practices
Good organizational, interpersonal and communication skills
Good judgement and decision-making skills
Strong influencing and negotiation skills
Strong computer skills including Microsoft Office and Data Management applications including EDC (Medidata Rave)
Demonstrated ability to work in a matrix environment
Excellent problem-solving skills
Ability to travel within the region/country
Ability to lead and motivate a training team
Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers