Senior Clinical Trial Manager

Location: Massachusetts
Specialisation: Life Sciences
Salary: Negotiable
Reference: BBBH10884_1658327692
Contact: Carlos Biggemann
Email: email Carlos
We are on the lookout for top performers who are as passionate about clinical research as we are clinical trial veterans and industry newcomers who will thrive in our fast-paced environment and help us drive new therapies to patients. Here is your chance to become a vital part of a growing global company in the expanding clinical research industry.



Job Responsibilities

· Responsible for ensuring that Clinical Team delivers timely and high-quality project deliverables.

· Site Management: Track and manage subject recruitment at all study sites. Oversee or supports the management of study Monitoring Visits, and review and approval of Monitoring Reports. Monitor study/site performance on an ongoing basis and escalate any infringements, breaches, and misconduct, fraud and trends at sites. Ongoing protocol deviation tracking, reporting, and trending. Notify sites of updates on global study information and updates.

· Study Start-Up: Uses operational and therapeutic expertise to optimize trial execution. Determine or contribute to the list of approved sites for selection visits. Plan or assist in allocating clinical team resources. Determine, develop and implement tracking and reporting specifications. Works with the study team to design clinical protocol; provides input for the design of the ICF template, source documents worksheets, and CRFs. Prepares and/or reviews study-related documents to include, visit report templates and annotations, clinical logs, forms, manuals and guidelines.

· Document and Supplies Management: Oversee or support the collection, review and filing of site essential documents, and maintenance of the TMF. Coordination of IP and clinical study supplies and oversee or support the overall tracking of clinical supplies at site in coordination with established systems such as IWRS, EDC, CTMS, or vendor-specific systems.

· Compliances: Follow international GCP guidelines/regulations, SOPs, and study protocol for executing clinical studies. Participates in the planning of quality assurance activities and coordinates or support the resolution of audit findings.

· Staff Management: Support Clinical Management Team or act as functional Manager to Clinical operations staff allocated on assigned projects. Provides coaching and guidance to junior Clinical staff.

· Daily interaction with the Clinical Management Team and members of the cross-functional study team.

· Support study management team in selecting sites and countries; develops relationships with investigators and site staff.

· Support the cross-functional study team as needed; frequent cross-functional interactions with internal and external personnel (e.g., regulatory affairs, investigators, vendors, etc.).

· Lead or partake in regular team meeting / teleconferences; Participate/present at Client Presentation Meetings as necessary; Participate/present at Investigator Meetings as necessary.

· Communicate any out of scope issues to the Senior Clinical Management Team or Project Management Team as soon as identified.



Ideal Background

Bachelor's degree in biomedical or related scientific discipline
Minimum 8 years of clinical research experience with a combination of clinical monitoring, study operations, and other relevant clinical research experience
Excellent organizational, multi-tasking, and time management skills required
Excellent verbal, written communication, and presentation skills.
Sound knowledge of medical terminology and expert proficiency level in clinical trial monitoring and management process.
Sound knowledge and understanding of ICH GCP and worldwide applicable regulatory requirements
Excellent skills at documenting study conduct and management.
Effective business skills for interactive situations with peers, sites, and clients.