Senior Manager Clinical Operations

About the role:
Senior Clinical Operations Manager Role – this role provides supervision, leadership, and line management of the Clinical operation team. This role will ensure that staff are trained and managed to conduct clinical trials according to ICH-GCP guidelines, local regulatory requirements, Novotech / client standard operating procedures (SOPs), and the Project Agreement. 

This role also provides direction and guidance to clinical teams in assigned project(s), coordinates site management and monitoring activities and provides operational leadership for clinical teams to achieve project deliverable

This role will contribute to training of staff and Senior Clinical Operations Manager may have responsibility for Clinical operations members in multiple country location and 1-2 layers of line reports in future.

 Minimum Qualifications & Experience: 

• Graduate in a clinical or life-sciences related field and/or line management experience within the pharmaceutical industry.
• At least 7 years’ experience in clinical research, including considerable monitoring experience as an CRA/SCRA or similar. CRO experience, line and/or matrix management experience are highly regarded.
• Previous Clinical Lead experience or a similar role is essential. 
• Must have a proven record in successful study management in large, complex studies.
• Must have an in-depth understanding of clinical trial regulation as well as site monitoring practice.
• Good analytical skills to understand and generate accurate data reporting using the relevant clinical trials management system.
• Good problem-solving skills.

Responsibilities:

 Project Execution and Delivery 

• Lead site identification and site selection activities. 
• Lead set up of clinical components in CTMS. 
• Prepare for and attend investigator meetings; may present materials.                                   

• Develop and distribute Clinical Monitoring Plan (CMP) and update as required 
• Develop and distribute Site Initiation Visit (SIV) materials.
• Develop and distribute Source Data Verification/Monitoring tools and trackers. 
• Develop and distribute annotated report templates and templates for visit confirmation/follow-up letters in accordance with any Sponsor requirements.
• Work with PM to coordinate initial shipment of both IP and non-IP supplies. Work with PM for re-supply of IP and non-IP. 
• Lead the CRA team to ensure all study materials are in place before SIV.
• Lead internal meetings/teleconferences with the CRA team.
• Prepare site newsletters/emails to keep site staff informed of key communication.
• Ensure the clinical team are adequately trained on project-specific requirements. 
• Develop and implement subject recruitment strategies at the study and site level. 
• Supervise CRAs to discuss subject recruitment strategies with sites, update recruitment projections, and improve site productivity. 
• Review CTMS compliance reports for clinical project team and follow up on gaps.
• Review Monitoring Visit Reports (MVR) and follow-up letters for compliance with ICH-GCP and the CMP; provide final approved documents to Sponsor as required and track report metrics in CTMS. 
• Track the resolution of follow-up issues from site visits. 
• Maintain protocol deviation tracking in CTMS
• Ensure appropriate issue escalation and tracking of these to resolution, proactive identification of areas of risk, and develop risk management strategies. 
• Oversee safety reporting processes to ensure in line with regulatory requirements.
• Provide guidance to CRAs through mentoring. 
• Oversee data collection and query resolution throughout the projects. 
• Oversee and coordinate the timely review and documented reconciliations of the TMF at the indicated timepoints per the project filing plan. 
• Assist PM with response to audit findings and assist the clinical team with completion of any CAPA review and documentation. 
• Work with PM to manage clinical resources to ensure monitoring activities are within budget and notify the PM of any changes required or changes in scope. 
• Assist PM to oversee the timely completion of site and investigator payment in accordance with the schedule detailed in the Clinical Trial Agreement.  
• May perform co-monitoring visits for ensuring site quality and CRA’s monitoring performance as request.  
• Oversees study transition plans of CRAs, ensures filing of the transition document/checklist. 
• Coordinate with PM and CRAs for Database Lock (DBL) and all close-out activities. 
• Oversee site close-out activities of the CRA team.

Learning and Development 

• Identify learning and development needs of staff.

 • Contribute to the delivery and training of staff. 

• Conduct accompanied monitoring assessments and co-monitoring visits to ensure compliance with SOPs, ICH-GCP guidelines and local regulatory requirements as per NVT/ Client guidelines. 

General 

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

• Identify areas of inefficiency and make recommendations for improvements. 

• Assist in the review and development of Novotech SOPs and guidelines. 

• Participate in activities of the clinical operations group, including coordination of and presentation at clinical team meetings. 

• Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry. 

• Establish and maintain relationships with key clinical trial sites and opinion leaders. 

• Establish and maintain relationships with local 3rd party vendors (e.g., Central laboratories, drug distribution depot, couriers, local regulatory consultants, and translators).

Business Development (if applicable) 

• Represent Novotech at conferences and meetings. 

• Understand local trial conditions and advise Operations and BD of any developments. 

• Identify opportunities to expand Novotech business within existing projects. 

• Represent Novotech at bid defence meetings. 

Work closely with the Japan Leadership:

• to support the design and development of Japan’s core functional capabilities
• to develop the hiring strategy for roles required Japan, ensuring alignment with organizational priorities and growth plans
• to promote and articulate Japan’s capabilities and value proposition to customers, strengthening our market presence and supporting business expansion
• to design and refine Japan’s delivery model to ensure operational excellence, scalability, and alignment with global standards

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.

• Act as line manager for one or more assigned CRAs, SCRAs, PCRAs; serve as a designated mentor to assigned clinical operations staff.
• Ensure induction process is completed as per company policy for all line reports on commencement of employment with the organisation.
• Ensure line reports are aware and understand company policies and procedures appropriate to their position.
• Meet regularly (in probation weekly or bi-weekly upon LM’s decision, moving to a minimum of monthly) with line reports to review their workload, welfare, and developmental needs.
• Set and agree written goals and objectives, perform annual appraisal interviews and end of probation appraisals; submit promotion requests to management as appropriate.
• Ensure management is aware of line report performance progress and informed of any issues arising.
• Ensure performance reviews take place in accordance with company procedures.
• Maintain promotion and succession plan for own teams.
• Review and approve leave requests for line reports in line with company policy.
• Ensure resource and recruitment are well aligned and timely managed in collaboration with relevant parties, participate in interviews for potential new hires.
• Actively seek feedback and monitor the quality of line reports work on an ongoing basis.
• Liaise with the Clinical Operations management team, Learning and Development and CRAs as necessary, to address individual learning requirements for line reports.
• Participate in activities of the Clinical Operations department, including presentation at clinical team meetings and, attendance at company meetings and contributing to the development of clinical processes and SOPs.

• Review and approve internal expenses within company policy.
• Ensure staff utilisation levels are maintained.
• Review and approval of timesheets of direct reports.

• Work alongside line reports to understand regional project objectives and facilitate local project delivery.
• In addition to above the Associate Manager may also need to perform Billable responsibilities of CRA or Clinical lead (refer to job description) on assigned projects.

• Identify learning and development needs of staff.
• Contribute to the delivery and training of staff.
• Conduct accompanied monitoring assessments and co-monitoring visits to ensure compliance with SOPs, ICH-GCP guidelines and local regulatory requirements as per NVT/ Client guidelines.

• Adhere to Company policies, procedures and guidelines and be quality minded in performance of duties.
• Identify areas of inefficiency and make recommendations for improvements.
• Assist in the review and development of Novotech SOPs and guidelines.
• Participate in activities of the clinical operations group, including coordination of and presentation at clinical team meetings.
• Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry.
• Establish and maintain relationships with key clinical trial sites and opinion leaders.
• Establish and maintain relationships with local 3rd party vendors (e.g., Central laboratories, drug distribution depot, couriers, local regulatory consultants, and translators).

• Represent Novotech at conferences and meetings.
• Understand local trial conditions and advise Operations and BD of any developments.
• Identify opportunities to expand Novotech business within existing projects.
• Represent Novotech at bid defence meetings.

• Contribute to training of staff and have responsibility for Clinical operations members across multiple country locations and 1-2 layers of line reports.
• To support and promote the Novotech Mission and Vision.

• Graduate in a clinical or life-sciences related field and/or line management experience within the pharmaceutical industry.

• At least 5 years’ experience in clinical research, including considerable monitoring experience as a CRA/SCRA or similar.
• Previous mentoring or staff supervision experience desirable.

• At least 7 years’ experience in clinical research, including considerable monitoring experience as a CRA/SCRA or similar.
• CRO experience, line and/or matrix management experience are highly regarded.

• At least 3 years line and/or matrix management experience within the CRO industry.

For all the above roles, relevant experience/qualifications in allied professions may also be considered.