Ref #: 26112

Employment type: Permanent - Full-Time

Location: US - East Coast

Posted: 08-Jan-2021

Description

DOCS is searching for a clinical research professional responsible for global coordination for the execution of unblinded drug management, including general facilitation of the Independent Drug Monitoring process between the Independent Drug Monitoring Team (IDM Team) and the Clinical Trial Team. Ensure IDM deliverables progress according to agreed upon timelines and in support of trial milestones; providing status updates, as required. Ensure inspection readiness through compliance with company Standard Operating Procedures (SOPs), codes
of Good Clinical Practice (GCP), other applicable regulations and guidelines from start-up through closeout. Takes ownership for assigned IDM responsibilities. This position is home-based but candidates must reside on the East Coast of the USA due to working global hours.

Responsibilities:

Lead study teams in management of IDM related processes and operations; ensuring blind.
Provide input for the development of pharmacy related materials, including forms and manuals.
System set-up including IVRS and EDC in a supportive capacity.
Ensure adherence to quality of the IDM process, including translation, documentation and escalation of major/critical issues in a blinded manner; follow up appropriately to closure.
Act as the main point of contact for resolution of any ad-hoc questions associated with IDM issues.
Resolve and document urgent/critical unblinded and pharmacy-related issues and investigate trends.
Monitor status and resolution of major/critical issues via Issue Logs and Visit Report review process.
Provide updates to Trial Team on pharmacy-related and compliance issues in a blinded fashion.
Take initiative to suggest and implement solutions to site-level issues.
Oversees Independent Drug Monitors (IDMs) to ensure investigational product activities are addressed at sites. Primary point of contact for the IDMs.
Provide communication and necessary information to IDMs on study updates, such as protocol amendments; potential to co-monitor IDMs.
Review IDM monitoring visit reports (initiation, periodic & closeout) and provide feedback, as needed.
Provide back up and support for the IDM.
Provide training & re-training to new IDMs and site pharmacy staff.
Ensure IDM visits occur within window and ensure any out of the window visits are tracked per process.
Ensure IDM monitoring visit reports and issue logs are up-to-date.
Ensure existence and accuracy of relevant IDM process documentation, communication and monitoring plans.
Provide input in audit and/or CAPAs.
Assist in database lock/interim analysis; cleaning unblinded data and reviewing unblinded queries, if applicable.
Create appropriate trial-specific IDM training materials and requirements.
Establish and maintain excellent working relationships with internal and external stakeholders.
Maintain Blinded TMF and perform document management activities.
Provide feedback to and train/coach/guide junior colleagues as needed.
Work proactively to increase global awareness of IDM processes; train and educate stakeholders.
Comply with relevant and on-time training requirements.

Qualifications:

BA/BA degree required
3-5 years of relevant experience in clinical trial operations in the pharmaceutical industry or CRO, prefer Lead Clinical Research Associate or Clinical Trial Management experience
Experience in Project Management mandatory, knowledge of databases and/or project management systems.
Strong working knowledge of ICH-GCP, local laws and regulations.
Effective leadership skills and ability to manage multiple stakeholders.
Experience and ability in coordinating teams in a virtual environment.
Solution oriented and proactive risk identification and mitigation.
Strong IT skills, including knowledge of standard industry systems and Microsoft applications;
willingness to learn new systems.
Monitoring experience is recommended; other relevant experience should be considered.
Willingness to travel locally/domestically.
Effective verbal and written communication skills.

DOCS is the FSP division of ICON Clinical Research. We provide 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.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

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