Home-Based/ Central Monitoring & Risk Management Specialist/ Pharma

Employer
DOCS Global
Location
United Kingdom, UK
Salary
Competitive
Closing date
16 Oct 2020

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Discipline
Clinical Research, Drug Safety
Hours
Full Time
Contract Type
Permanent
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Job description:
Central Monitoring & Risk Management Specialist's (CMRMS) responsibilities include working within the Risk Management-Central Monitoring Group and leads clinical study teams in the study-specific design and implementation of Analytical Risk-Based Monitoring (ARBM) on clinical trials (Ph I-IV). CMRMS is responsible for a range of tasks that spans the areas of risk identification & mitigation, data analysis, leading cross-functional teams, communicating with study team members on multiple levels, providing ongoing training on ARBM-related processes to teams, and participating in departmental initiatives related to innovation and process improvement.

Deliverables:
• Services will adhere to SOPs, policies, local regulatory requirements, etc.
• Lead central study teams (including trial managers, data managers, study physicians, study scientists, quality colleagues, and statisticians) in the identification of critical study data/processes and in related potential risks.
• Coordinate trial team translation of identified risks and critical data/processes into risk mitigation and oversight plans to be followed during study execution.
• Lead the central study team in making appropriate decisions regarding site management, data review, and contingency plans and provide their own input into related study plans.
• Coordinate with the cross-functional central study team to ensure compliance with the risk oversight plan established during ARBM design and to oversee site risk parameters.
• Responsible for ongoing study and operational data reviews, as well as associated follow-up to resolution of their findings in conjunction with appropriate central and field team members. This is to be accomplished through the utilization of multiple internal systems, internal/external databases, custom report creation, and the use of a selection of data analysis and visualization tools, followed by the proper interpretation and investigation of risk indicators and trends.
• Successfully lead recurring cross-functional study team meetings inn a virtual environment. Organize, lead, document meetings, communicate effectively, and guide and influence colleagues in new methodologies is critical.
• Ensure Inspection readiness for sites by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS and eTMF) according to expectations (metrics) and archiving retention requirements, including storage in a secure area.
• Complying with relevant training requirements and developing therapeutic knowledge sufficient for role and responsibilities to ensure inspection readiness.
• Full utilization by timely and accurate time reporting.
• Supporting capacity to a Primary Central Monitoring Manager

Education and Experience Requirements:

• BS degree, Master's Degree or Equivalent.
• 3 or more years of Clinical trials experience required (i.e. clinical operations, data management, statistics, or other relevant clinical development experience) in the pharmaceutical/medical device industry.
. Would also suit a well experienced In house CRA, Central Monitor or Remote monitor OR an experienced CRA who is looking for a in house role.
• Possession of a strong analytical capability and mindset.
• Knowledge of ICH-GCP and overall drug development processes.
• Ability to operate and proactively use various systems and databases (CTMS, Rave, KPI Dashboard, Spotfire, etc.) to analyze trial quality/performance and compliance and identify trends and potential signals.
• Data analysis and technical skills in clinical trials/clinical data.
• Ability to successfully work with global and remotely based teams.
• A robust understanding of the principles of proper issue escalation and resolution.
• Advanced communication skills allowing smooth and effective communication lines and the ability to manage multiple communication streams.
• Ability to work with a set of predefined common risk, and ability to adapt/be flexible to adapt to protocol-specific risks.
• Team lead experience or functional management experience.
• Specific therapeutic area experience depending on the services need.
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.
• Proficient in speaking and writing in English. provided. Good written and oral communication skills as appropriate.


DOCS provides global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry. 

 

Our Values

At DOCS, we are driven by our core values that guide our culture and support our goal to become a Trusted Partner. Our five core values are:

OUR PEOPLE: We attract, source, develop and retain the best talent to enables us provide world-class people and solutions for our clients.

EXCELLENCE: We never stop looking for new, better ways of working.

ACCOUNTABILITY: We take responsibility for our actions, owning our client’s problems and proactively looking for solutions.

INTEGRITY: Becoming a trusted partner means being honest, respectful and ethically sound, at all times.

OPENNESS: We encourage and facilitate an open and inclusive environment for a diverse global network of employees and stakeholders.

Contact Us
  • 2 Globeside
  • Globeside Business park
  • SL7 1HZ
  • United Kingdom
  • +44 (0) 2380 688500
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