Menu

Regional Clinical Trial Manager

at DOCS in Dover, Delaware, United States

Job Description

Regional Clinical Trial Manager

Ref #: 31770

Employment type: Permanent – Full-Time

Location: US – remote

Posted: 24-Sep-2021

Description

ICON Global Strategic Resourcing is currently seeking an experienced Regional Clinical Trial Manager, remote home based in the US.

Key Responsibilities

• Leading the regional matrix team (e.g. CRA, CTA, etc.) to ensure delivery of country and site level study activities in alignment with the global study project plan

• Identifying and resolving issues at a regional level

• Collaborating with Global CTM to ensure country level study delivery is aligned with the global study project plan

• Contributing to study-level risk assessments

• Leading and continually review regional risk mitigation activities to ensure study delivery to plan

• Overseeing regional insourcing/outsourcing partner deliverables to the required standards Partnering with Tech Services, Supplier Governance and Electronic Trial Operations – to ensure regional, country and site vendor set-up, conduct and quality Leading regional documentation and required tool and systems set-up

• Contributing to regional aspects of Drug Supply Plan

• Ensuring implementation of study(ies) in accordance with SOPs and ICH/GCP guidelines

Basic Qualifications

• BA/BS/BSc or RN

• Broad experience working in life sciences or medically related field, including general biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company)

Preferred Qualifications

• BA/BS/BSc in the sciences or RN

• Previous management experience of direct reports

• Experience in oversight of outside clinical research vendors (CROs, central labs, imaging vendors, etc.)

Knowledge

• Working knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP), and applicable international regulations and guidelines

• Clinical Development process and procedures

• Project planning experience including oversight of study deliverables, budgets, and timelines

• Ability to use scientific and clinical knowledge to conceptualize study designs

• Experience anticipating and resolving problems

• Experience writing and presenting clearly on scientific and clinical issues

• Experience collaborating and leading cross-functional teams (team/matrix environment)

• Knowledge of project risk management assessment and mitigation approaches

Key Competencies

• Project Management

• Risk assessment

• Critical Thinking and Planning

• Matrix Team organization/leadership

• Metrics analysis

• Written and oral communication

• Delivery focus

• Decision Making

• Problem solving

• Relationship management

• Conflict resolution

• Adaptability and Flexibility

• Working in virtual teams

Icon Global Strategic Resourcing is currently seeking an experienced Country Study Manager

Country Study Manager Role

Key Purpose

• Primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up to close out at a country level in accordance with ICH-GCP and applicable local regulations

• Maintain the quality and scientific integrity of clinical trials at a country level

• Collaborates with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables within the country

Key Activities

• Planning, management and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST)

• Accountable for study deliverables in that country.

• Leads country-level operational planning and supports site selection within region

• Ensure relevant systems are updated to enable accurate reporting of study progress and milestone deliverables

• Ensure key stakeholders are kept informed of study progress e.g. GCTM, DOM

• Contribute to development of study-specific materials – e.g. monitoring plan, study specific training documents.

• Provides input into the Country Operational Plan (COP) and partner with the DFM and GCTM to ensure regional delivery of the Global Study Operational Plan (GSOP)

• Support and contribute to Trial Management Teams (TMTs), agenda driven presence at meetings and daily huddle as required

• Communicate country status (including timelines and deliverables) to key stakeholders (e.g. TMT, GCTM, Program Managers) and ensures updates to relevant systems

• Contributes to site-level goal setting and study-specific deliverables for clinical sites within their country

• Coordinates cross-functional review of issues escalated directly from sites or via the CRA and facilitates resolution

• Contribute to, deliver and/or lead CRA, Investigator and Study Coordinator training

• Oversight and monitoring of applicable vendor activities eg. laboratories and equipment provisioning

• Monitor the execution of the clinical study against timelines, deliverables and budget for that country

• Monitor country enrolment and retention and act on deviations from plan. Identify barriers to enrolment and support recruitment and retention strategic solutions.

• Monitor and act upon data flow metrics – review, trend identification and analysis, with targeted follow up where appropriate

• Monitor and review country/regional trends

• Review Monitoring Visit Reports

• Contribute to the study-level forecast for investigational product, support study level accountability and reconciliation across multiple countries, management of ELE process

• Identify and facilitate resolution of cross-functional study-specific issues

• Provide updates regarding the study budget and obtain approval for budget deviations for clinical sites (outside of range)

• Escalate any issues related to delivery, timelines or budget to GCTM or TMT lead if appropriate

• Execute regulatory agency inspection readiness activities (e.g. TMF review, story board generation)

• Participate in cross-functional task forces/process improvement groups

• Assign and oversee deliverables of study support staff e.g. Study Management Associate, CTS

• Member of the Global Clinical Studies Team (GCST)

Preferred Qualifications

• BA/BS/BSc

• 7 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company

• Experience in oversight of external vendors (e.g. CROs, central labs, imaging vendors, etc.)

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career – both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will recei

Copy Link

Job Posting: JC192019799

Posted On: Sep 10, 2021

Updated On: Oct 08, 2021