Senior Manager Clinical Operations - Thailand

Role & Responsibilities 

Line Management 

• 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. 

Finance 

• Review and approve internal expenses within company policy. 

• Ensure staff utilisation levels are maintained. 

• Review and approval of timesheets of direct reports.

Project Execution and Delivery 

• 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. 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).

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.

Business Development (if applicable) 

• Represent Novotech at conferences and meetings and 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.

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 montitoring experience as a CRA/SCRA or similar.  
• At least 3 years' of line and/or matrix management experience within the CRO industry.

We offer hybrid working arrangements and full flexibility in working hours to ensure our staff achieve the work-life balance often missing in this role.

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.

You must have full unrestricted working rights in Thailand to be considered for this role. We unfortunately cannot provide sponsorship for this role.