Job Description

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Brief Position Description:

The Manager Centralized Document Management is primarily responsible for providing supervision and line management of clinical operations staff dealing with centralized trial master files as assigned.The Manager will provide support to the group of Document Management Associate (DMA) in day-to-day activities of Centralized Document Management within the clinical

team. This role will be responsible for line management and oversight for DMAs, SDMAs and CDS and working with all relevant stakeholders within project team and assisting with all management aspects for project Trial. Master Files (TMF), both electronic and paper, in a format according to project requirements, ICH GCP guidelines, local/global regulatory requirements and Novotech/Client SOPs.

Minimum Qualifications & Experience:

• At least 10-12 years of experience in clinical research across all stages and phases of trials with previous exposure to line or matrix management preferred.

• Practical experience in handling Trial Master File activities including Paper or electronic - TMF (eTMF). Prior background in the pharmaceutical, CRO or healthcare industry is advantageous.

• Line Management experience is essential.

Responsibilities:

Line Management:

• Act as Line Manager for assigned staff including Team Lead, Centralized Document Management, DMA, SDMA and CDS.

• Work with the Resourcing Co-Ordinator to identify appropriate project assignments for direct and indirect line reports, identify shortfall in resourcing and trigger hiring requests, as necessary.

• Work with HR to ensure recruitment activities and candidate selection occur in line with business needs.

• Coordinate induction process for all new line reports on commencement of employment. Ensure line reports are aware of and understand company policies and procedures appropriate to their position.

• Determine employees\' career goals and objectives to facilitate their career progression and retention of staff. Perform formal performance appraisals at mid - and end - of probation and annually according to HR schedule.

• Ensure balanced workload and project assignments in line with employees\' skills and experience. Meet regularly (in probation period, weekly, moving to a minimum of monthly) with line reports to review their workload, welfare, and developmental needs.

• Actively seek feedback and monitor the employee\'s performance metrics and KPIs, as well as the quality of their work, on an ongoing basis. Provide constructive and developmental feedback to ensure performance standards are maintained.

• Liaise with the Clinical Operations Management Team, Learning and Development Manager and Project Managers as necessary, to address individual learning requirements for line reports and ensure ongoing training compliance.

• Provide updates to management on employee\'s performance, development, and progression, as well as any performance issues or negative client feedback.

• Ensure team retention and engagement scores are within set organizational requirements.

Functional Management:

• Lead the team in developing all TMF-related processes, tools, training and working practices in collaboration with Senior Clinical Operations Management team.

• Provides expertise and best practices related to the TMF, including EDs, TMF processes and eTMF systems, and other clinical trial processes.

• Ensure the document quality requirements are agreed to and met by the study team, according to Completeness, Timeliness and Quality metrics.

• Develop and implement key quality and compliance goals and objectives.

• Responsible for ensuring projects are appropriately resourced to a DMA, SDMA, CDS.

• Present or represent Novotech at professional meetings, present the team and function at internal team meetings as required.

• Contribute to the preparation, review, approval and delivery of clinical training to clinical team members.

• Mentor new employees in specified TMF tasks and duties, if required. Undertake other related duties as assigned.

• Ensure adherence to Company policies, procedures and guidelines and be quality minded in performance of duties.

• Assist in the review of clinical SOPs and processes. Identify areas of inefficiency in processes, and male recommendation for improvements.

• Participate in activities of the Clinical Operations Group, including presentation at internal team meetings and delivery of training.

• Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry; ensure all communications with external parties and the performance of the study team presents a positive professional image of the company.

About Us: Novotech has offices in 11 geographies across the region, and site partnerships with key medical institutions.

Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.

About the Team: Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services.

It has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally.

As of September 30, 2021, Novotech had over 2,750 FTEs across 11 geographies in Asia-Pacific, the United States and the UK.

Novotech