eTMF Manager/Clinical Trial Manager - Hemavant Sciences

Job Summary:

The eTMF Manager/Clinical Trial Manager (CTM) assists the Clinical Operations team with clinical trial execution activities, and ensures trial deliverables are met according to timelines, budget, operational procedures, quality standards, GCP, SOPs and business guidelines. This role will also manage filing and maintenance activities for clinical trials during the study start-up, maintenance and close-out periods.

Responsibilities:

• Serve as the primary point-of-contact for all TMF related activities.
• Ensure TMF processes and related documentation are of the highest quality and that they comply with ICH regulations, GCP guidelines and expectations of regulatory authorities.
• Conduct oversight of the third-party vendors supporting TMF activities to ensure service meets expectations.
• Maintains effective communication with clinical study teams, CRO staff, and eTMF vendor personnel throughout study start-up, maintenance and close-out.
• Supports TMF document filing into Hemavant’s eTMF system.
• Maintains a naming and filing guide specific to eTMF documents.
• Performs routine quality checks of documents uploaded into the eTMF.
• Responds to inquiries regarding eTMF management and contents.
• Runs routine eTMF reports and monitors TMFs for completeness and trends.
• Completes other TMF document-related tasks as required by the study teams or the Clinical Operations department.
• Track and report on progress of study site activation, patient enrollment, and monitoring visit activities.
• Oversee and manage vendor performance, internal metrics, risk management and communication of trial status within and outside the trial.
• Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
• Participates in the preparation and review of business processes and SOPs.

Minimum Qualifications – Education and Experience

• Bachelor or higher degree in the health or life sciences or equivalent
• 5 year’s experience in clinical trials (e.g., study coordinator, regulatory operations) and of eTMF document management experience.
• Good communication and interpersonal skills in managing a cross-functional team
• Proficiency with clinical research documents, their contents, and purpose, and working knowledge of GCP and regulatory requirements.
• Strong organizational/prioritization skills for the management of workload with attention to detail a must.
• Demonstrated proficiency with eTMF applications (Veeva Vault Clinical eTMF experience a plus), word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint).
• Work in a flexible remote environment that sometimes requires flexibility to meet early or late day so that interactions with global partners and staff can take place.
• Sound working knowledge of the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory guidelines required.