Clinical Project Manager at Bioforum the Data Masters

Minimum requirements:

• Bachelor’s degree or above in a biomedical or science discipline and equivalent experience is required.
• Knowledge of data management processes.
• Microsoft Office and EDCs knowledge is required. 

Minimum experience:

• At least 4 years of experience in a clinical research environment

Minimum requirement/skills:

•  Knowledge of clinical trial process flow.
•  Microsoft Office and EDCs knowledge is required.

Minimum requirement/competencies:

•  English proficiency is required.

Responsibilities:

•  Overall and main responsibility of all DM activities for the assigned studies
•  Expertise in protocol and study conduct and ensure that the DM activities and deliverables meet the requirements within scope, budget and timelines
•  Supervise database development and quality data definitions and execution from study start up to database lock
•  Focal point of communication with sponsors
•  Build positive and collaborative relationships with Sponsors envisioning long term collaborations
•  Provide activates progress and status to VP DM and sponsor on ongoing basis as defined per study
•  Assign and allocate resources for all the required study activities
•  Supervise Data Operations Managers on database creation
•  Collaborate with Business Development and DM VP and to ensure the DM package offered for new proposals meet the study needs – including tailored made solutions and premium products as applicable
•  Supervise TMF completeness by Clinical Quality Control Associate and seek QA guidance as needed
•  Ensure study conduct is according to SOPs, WI and ICH GCP
•  Appraise the head of all relevant departments to obtain conformance/approval at all stages of the project
•  Supervise Data Review/Reconciliation/Coding and review Checklists to completeness of study activities on time
•  Lead creation of Validation and UAT scripts and execution
•  Collect all signatures required by sponsor prior to each milestones
•  Collaborates with QA and VP DM to address CAPAs as needed
•  Ability to work independently and manage company and sponsor’s stakeholders
•  Proven outstanding communication, problem solving and collaboration skills
•  Proven ability to meet or optimize timelines and budget cost effectiveness
•  Contribute to improve current processes following regulations
•  Update knowledge of DM processes
•  Mentor and knowledge sharing to other DM members