MSD Associate Clinical Research Manager 

Portugal, Lisbon 

3419894

Job Description

Responsibilities include but are not limited to:
• Project management of the assigned studies, with proactive planning, driving of the Team and tracking execution and performance of deliverables/timelines/results to meet country commitments from feasibility, site selection, recruitment, execution and close out.

• Review of monitoring visits reports and escalation of performance issues and training needs to internal management and functional vendor as applicable and needed.

• Leading local study teams to high performance. Responsible for training in the protocol and close collaboration with and support CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration.

• Creation and execution of a local risk management plan for assigned studies and execution of quality control visits as required.

• Ensures compliance with CTMS, eTMF and other key systems in assigned studies.

• Escalates as needed different challenges and issues to Country Lead, Clinical Research Director, Country Quality Manager or Clinical Trial Team (as appropriate).

• As a customer-facing role is responsible for collaboration and business relationship with functional outsourcing vendors, investigators, other external partners, or stakeholders, in assigned studies.

• Internal collaboration with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Regulatory Affairs and Global Medical and Scientific Affairs.

Competency Expectations:
• Knowledge in project, site and time management, and organizational skills is essential to this position. Expertise in core trial management systems and tools.

• High interest in clinical research and continuous scientific learning is required.
• Ability to make decisions independently and to oversee important activities relevant to clinical research activities.
• Effective communication and collaboration spirit in a remote/virtual environment and across countries, cultures, and functions.

• Strong leadership, empathy, interpersonal and conflict management skills.
• Demonstrated ability to build relationships and to communicate effectively with external customers (e.g., sites and investigators)

Background & Experience:

• Bachelor’s degree (e.g. BA/BS or higher) in Life Science or equivalent Health Care related experience.

•Minimum of 5 years´ experience within Clinical Research and 5 years' experience as CRA monitoring clinical trials.
• Excellent verbal and written, training/mentoring skills, in Portuguese and English.

• Excellent working knowledge of all applicable ICH/GCP regulations and Good Documentation Practices and ability to work within these guidelines.

Current Contingent Workers apply

Not Applicable

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.