Medical Monitor

Artech LLC.; Lawrence Township (NJ); Ibrido; USD 100.000 - 130.000; Tempo pieno

Descrizione del lavoro

An IT staffing company in New Jersey seeks a Clinical Trial Medical Monitor to oversee oncology studies. The ideal candidate will have an MD or DO with 3-5 years of industry experience, especially in clinical trials Phase I-III. Responsibilities include monitoring studies, reviewing safety data, and communicating with various stakeholders. The position offers flexibility to work remotely with some onsite requirements for training and onboarding.

Competenze

• Minimum of 3 - 5 years industry experience.
• Experience as a medical monitor for clinical trials (Phase I - III).
• In-depth knowledge in Oncology.

Mansioni

• Monitor and clean ongoing oncology studies and support database locks.
• Review safety data using various tools.
• Attend and present at Investigator meetings.

Conoscenze

Communication skills

Project management

Matrix organization experience

Formazione

MD or DO

Strumenti

J-Review

CIOMS

CFR imaging tools

Descrizione del lavoro

Artech is the 10th Largest ITStaffing Company in the US, according to Staffing Industry Analysts' 2012annual report. Artech provides technical expertise to fill gaps in clients'immediate skill-sets availability, deliver emerging technology skill-sets,refresh existing skill base, allow for flexibility in project planning andexecution phases, and provide budgeting/financial flexibility by offeringcontingent labor as a variable cost.

Job Description

• Clinical Trial Medical Monitor

Role Imperatives

• Work with Clinical Trial Lead/Program Lead or Early Asset Development Lead and cross functional study team to monitor and clean ongoing oncology studies, and support database locks.
• Work with the clinical team to review the safety data using different tools: J-Review, CIOMS and CFR imaging tools.

Essential Core Behaviors

• Ability to work and communicate efficiently with internal partners
• Working effectively in a matrix organization
• Ability to work independently

Desired Background, Knowledge, And Experience

• MD or DO with experience in Oncology
• A minimum of 3 - 5 years of industry experience
• In depth knowledge of and experience as a medical monitor for clinical trials (Phase I - III)
• Good verbal and written communication skills essential
• Experience managing projects in a matrix environment, coordinating activities and adhering to tight timelines
• Excellent written and verbal communication skills are required
• Attend weekly update meeting with BMS core team (PM, DM, stats, CRO) as required
• Respond to site and Health Authority questions about the protocol
• Weekly investigator calls for Phase I studies as needed
• Monthly review of Jreview and CRO data listings and QNET lab data. Attend monthly safety meetings
• Review daily lab alerts and SAEs. Communicate with CRO sites regarding follow-up.
• Monthly review of protocol deviations
• Attend and present at Investigator meetings
• CRF review
• Present study updates as needed
• Design and implement safety monitoring plans
• DBL (final listing review, review of blinded TLF, review protocol deviations, participate in all DBL meetings)
• CSR writing (review final TLFs, work with medical writer to review & revise CSR document, draft discussion and conclusions, participate in comment resolution meetings)
• Topline results presentation
• Other tasks may be required as determined during the project by BMS
• The position is preferably based in the Princeton, NJ area but working remotely with occasional face to face meeting acceptable depending on business needs. Will need to be present in NJ for initial onboarding/training.

Qualifications

• MD or DO with experience in Oncology
• A minimum of 3 - 5 years of industry experience

Additional Information

All your information will be kept confidential according to EEO guidelines.