Clinical Project Manager

Clinical Project Manager at ICON Strategic Solutions in Boise, Idaho, United States Job Description The Clinical and Exploratory Pharmacology (CEP) Clinical Trial Manager (CTM) is responsible for the overall operational planning and activities for the implementation and conduct of clinical exploratory pharmacology clinical trials in compliance with ICH, GCP's, SOPs, local requirements, internal / departmental guidelines, and established timelines.

The CTM is involved in the operational planning and scientific conduct of the clinical trial and acts as the leader of operational disciplines (Clinical Trial Team (CTT)) to guarantee release of homogeneous high quality clinical data in close collaboration with the CEP Data Manager (DM) and Clinical Study Director (CSD).

The CTM may manage studies at the product level (if applicable). The CTM can be involved in field monitoring activities of his / her own studies according to workload / need and / or manages local monitoring or outsourced monitoring.

The CTM may also participate in intra or inter- department Working Groups. Provide management and oversight of clinical trials (which may include complex, multiple center and multinational proof-of-concept studies) to ensure progress according to study timelines.

Lead the Clinical Trial Team (CTT) including representatives of all operational disciplines involved in the conduct of trial (i.

e., CRAs / CROs, Data Management, Pharmacovigilance, Clinical & Exploratory Pharmacology Sciences, Biostatistics, Pharmacokinetics, Clinical Supplies, and other relevant departments, platforms or units).

• Manage the study according to Good Clinical Practices (GCPs) and local and / or national regulations, with responsibilities on product and project level.
• Collaborate with team members on a day-to-day basis; in particular, build a strong collaboration with the study Data Manager (DM) and the Clinical Study Director (CSD).
• Anticipate bottlenecks in all steps of the study and development / implementation of counteractive measures - Solve or coordinate the resolution of issues during conduct of the trial - Develop and review specific study-related documents - Develop and coordinate the study budget, including invoice validation - Contribute to contract process - Manage investigational product supplies (ordering, packaging, and shipment) - Participate in and contribute to internal audits, if applicable - Serve as main contact for clinical sites and other outsourced activities - Manage local MT (CSUs) when applicable - Manage outsourced centralized activities when applicable (Central Lab) - May perform studies following some Phase 2-3 processes when applicable (multicenter- multicountry Phase 2a trials) Collect, synthesize, report, file and prepare archiving for clinical trial activities.

Manage CRO / study sites Escalate quality issues and delays in deliverables, propose solutions, request and ensure follow-up actions Assess CRO performance by completing CRO post services assessments Conduct yearly CRO assessment, if applicable Manage outsourced / sub-contracted monitoring activities, when applicable.

Lead study-specific training - Manage performance of monitors - Review and approve all visit reports Conduct field monitoring activities, if required - Set-up and manage site visits (Site Initiation Visit, Interim Monitoring Visits, Closure Visit) including in-house preparation such as data listings review - Attend site visits as primary or co-monitor (e.

g. when mentoring Associate CTMs) - Conduct source data validation and other monitoring activities (according to the study- specific Monitoring Plan, if applicable) - Use eCRF tool for ongoing data review and query generation - Regularly review and reconcile the Investigator Study File, Investigational Product accountability and biological sample management - Report visit progress / findings to CSD and other relevant members of the CTT and Site manager - If applicable, review visit reports Participate to the mentoring and training / coaching of Associate CTMs, apprentices or trainees - Utilize department mentoring program - Track mentoring / training progress by meeting with mentee on regular basis Participate in intra or inter-department Working Groups, if applicable - Propose and implement process improvements - Participate in development / improvement of guidance documents Other leadership activities : - May serve as internal consultant for specific departmental activities, if applicable - May serve as Project leader for the department or external to the department : be the referent for a specific compound and maintain accurate documentation available for the department, participate in Project Team meetings, if applicable UNITED STATES : Bachelor's Degree + 8+ yrs.

laboratory or medical experience 5+ years in clinical research EUROPE : BAC +4 / 5 (Master's Degree) 5+ years minimum in clinical research, including an international background Field monitoring experience or related experience is required (approximately 3-5 years).

Strong English communication skills (verbal and written) if English is a second language. Clinical Trials Management or Project management experience (approximately 3-5 years) and recognized in cross functional operations.

Previous Phase I experience preferred Knowledge of data management activities Experience with management of outsourced activities Why 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.

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.

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 receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

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