Key Purpose :
Working under the direction of the department head, the Manager, Site Management & Documentation is responsible for the management and oversight of assigned team members, to ensure project deliverables are met for Site Management & Documentation.
The Manager, Site Management & Documentation, maintains optimal department processes, implements project-specific strategies, and assists with the development and implementation of department strategies to increase productivity and quality.
Primary Duties + Responsibility :
Responsible for the direct management of assigned Site Management & Documentation team members, including performance management, career development and growth, training, and employee relations.
Responsible for ensuring that trials are inspection-ready at all times through the execution of assigned studies, and effective oversight of assigned team members.
Demonstrates thorough knowledge of, and coaches others in, the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable SOPs and policies.
Leverages resources, expertise, and knowledge across multiple projects to ensure attainment of project deliverables from project start to completion.
Provides oversight to TMF set-up and maintenance, as well as training and site payments, across multiple studies.
Participates in assessing hiring needs, interviews, hires and trains to align with the needs of the department.
Leads and / or participates in quality assurance and continuous improvement activities as they relate to Site Management & Documentation including development and review of department policies, SOPs, and other controlled documents, as well as participation in audits / inspections.
Assists department leadership with setting departmental goals and strategic long-term planning for the department.
Ensures effective communication with external and internal customers.
In conjunction with department leadership, develops and implements training activities for departmental staff to promote high quality standards and increased productivity, and to drive efficiency in processes.
Provides regular updates regarding the status and progress of Site Management & Documentation activities for the trials.
Identifies project risks and develops and implements the mitigation strategies for these risks, as it pertains to Site Management & Documentation.
Participates as a leader in departmental initiatives.
Contributes to the creation and maintenance of study specific TMF Management Plans, and all other relevant documents including but not limited to TMF reference model, in association with the project manager.
Serves as the subject matter expert in providing training on Site Management & Documentation processes and procedures, including but not limited to TMF, document requirements and ICH / GCP guidelines.
Leads by example and models core values in all actions; ensures a positive, respectful team environment, fostering collaboration and development.
Experience & Minimum Requirements :
Bachelor’s Degree in a science or related field preferred.
8 years of clinical development experience required, with at least 3 years of supervisory experience or 5 years of project lead experience.
Ability to effectively manage a remote and / or geographically dispersed team.
Experience in site documentation management.
Excellent written and oral communication, organizational and interpersonal skills required.
Excellent working knowledge of drug development process and clinical research methods, including TMF maintenance, study start-up activities, and site engagement.
Proven clinical development experience in the operational aspects of clinical studies, including the ability to mentor, coach and train assigned team members.
Action-oriented and resilient in a fast-paced environment and will have the ability to build effective project teams, motivate others, delegate, and make and implement decisions.
Ability to build and maintain trust and confidence and communicate effectively with clients, external vendors, and internal team members.
Excellent oral and written communication skills in English (other languages a plus), to effectively support and manage exchanges with external customers.
Proficient knowledge of study specific therapeutic area to enable appropriate input to study documents.
Proficient in clinical systems including EDC, IVRS, CTMS, eTMF and other project management tools.
Additional Requirements :
Driving / Travel requirements - Travel up to 25% (US, Canada, or International)
Physical requirements ability to occasionally lift / move up to 25 lbs.
Hours / Conditions US : 40 hour work week; Canada & UK : 37.5 hour work week
FLSA Classification Exempt