Clinical Study Manager

ProClinical is currently seeking a Clinical Study Manager for a pharmaceutical company located in Boston, MA. Successful candidate will independently manage the operational aspects of clinical trials, including vendors such as CROs, central labs, biomarker and specialty laboratories, and clinical trial sites.

Job Responsibilities:

• Identifying and qualifying clinical trial sites and investigators alongside CRO including management of key relationships.
• Participating in the day-to-day supervision of clinical trial execution, focusing on site start up, enrollment, monitoring, compliance, and data flow metrics from the clinical sites, CROs and central labs
• Managing clinical study budgets and execution timelines.
• Leading internal team meetings for study management.
• Facilitating investigator meetings, kick-off meetings, monitoring training, and various CRO meetings.
• Participating in the development of clinical trial protocols, amendments, CRFs, IRB/Ethics applications, and recruiting materials.
• Attending at site visits to ensure oversight of CRO monitors and effective collaboration with Investigators and site staff.
• Reviewing study reports and metrics to ensure timely collection of clinical data, samples, and lab results.
• Collaborating on SOP development and promotion of standardized clinical business tools.
• Developing and reviewing specific study documents.
• Developing action plans to address protocol compliance, safety, data and administrative issues with investigational sites and CROs.
• Participating in the preparation of presentations of trial data for internal and external parties.

Skills and Requirements:

• BS in a scientific discipline required. MS/PhD preferred.
• 4-6+ years in trial management with a sponsor company managing various phase clinical trials.
• Experience in various phases of clinical trials and various therapeutic areas.
• Experience in CRO, vendor and laboratory oversight required.
• Motivated self-starter who is capable of flourishing in a fast-paced small company environment.
• Creative problem solver with excellent communication and public speaking skills.
• Strong interpersonal and organizational skills are needed, with a high degree of attention to detail. Ability to interact well with individuals at all team levels (e.g., Clinical scientist, Project leader, Physician, etc.).
• Ability to travel for up to 30% of time, both domestic and international, may be needed.
• Detailed knowledge of GCP and current US FDA regulations, and knowledge of other relevant global regulatory requirements a plus.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Miles Tobin at (+1) 617-545-5922 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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