Clinical Research Associate Manager

Há 3 dias

Paço de Arcos, Portugal MSD Tempo inteiro

Job Description

Reporting into the Clinical Research Country Lead, the person will ensure strong monitoring in our clinical trials, development of the team and country capabilities. Will be responsible to manage a team of CRAs and ensure excellent study and site performance, high quality standards with strict adherence to local regulations, company SOPs and Policies and ICH GCP.
 

Responsibilities include but are not limited to:
• Allocation of work and CRAs training, mentoring, development, and performance, including addressing low performance situations, and taking appropriate actions.

• Provides input for capacity planning and efficiency, including reporting of current resources and forecasting of CRA needs. Liaise with local HR and finance functions as required.
• Work with CRAs, PLMS and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability. Support and resolve escalation of issues.
• Interface with GCTO partners on clinical trial execution.

• Interacts with sites as needed to resolve site or CRA operational issues to meet commitments in a timely manner in coordination with the study CRM.
• Attend local Investigator Meetings as needed.
 

Competency Expectations:
• Excellent people management, time management, project management and organizational skills is essential to this position.

• Ability to work independently and in a team environment is required.
• Skills and judgment required to be a good steward/decision maker for the company
• Expertise in and excellent working knowledge of core trial management systems and tools
• Strong leadership skills and high emotional intelligence in people management
• Excellent interpersonal and communication skills and conflict management.
• Demonstrated ability to build relationships and to communicate effectively with external customers (e.g. sites and investigators)
 

Travel: up to 50% time

Training & 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 of 3 years’ experience as CRA monitoring clinical trials.
• Line management experience preferred or at the minimum team leader experience.
• Excellent verbal and written, negotiation and 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 Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

07/7/2024

*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.


Job Posting End Date:07/07/2024


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.


Requisition ID:R301137

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