Clinical Project Manager

Required
1. Bachelor’s degree, typically in a scientific discipline.
2. A minimum of 3 years clinical trial experience in CRO, Pharmaceutical or Biotech compan
3. Clinical trial monitoring experience and site/CRO management experience
4. Possess thorough knowledge of ICH GCP guidelines, Industry regulations and quality standards.
5. Significant project management experience in healthcare industry, preferably in product development, project management, and/or medical affairs operations.
6. Demonstrated successful working experience within a matrix organization, able to work within team and at times autonomously.
7. Proven decision-making skills leading to successful outcomes and strong ability to problem solve.
8. Fluent in written and verbal business English.
9. Experience working in a regulated environment (GCP).
10. Knowledge and/or experience working with groups with varied cultural backgrounds.
11. Significant knowledge of drug development and product lifecycle management processes.

Preferred
1. Proven project/programme management experience, with demonstrable experience of assessing feasibility of studies, determining patient population, authoring and reviewing key clinical trial documents and working with cross-functional study teams.
2. Clinical Trial experience at Project manager level
3. Track record of managing multiple projects
4. Financial acumen to determine and manage study budgets, reconciliation and explaining variances within agreed timelines and budget.
5. Strong cultural and interpersonal sensitivity and collaborative approach when resolving challenging situations.
6. Clinical trial monitoring experience.
7. Additional Asian language
8. Experienced in working across multiple cultures and countries.

This position ensures successful oversight of MA-AO and affiliate activities:
1. Provides specialist project management expertise to ensure consistent and effective execution of Regional and Local projects documented in the Core Medical Plans (CMP) across all therapeutic areas.
2. Responsible for managing timelines, budgets, resources and risks related to key strategic operational activities. This includes clinical programmes, non-interventional programmes, publications, advisory boards and other therapy / product related activities or projects.
3. Collaborates effectively with internal stakeholders, including Regional TA and Local MA teams, by building relationships across the Medical Affairs organizations and other functions to align activities.
4. Manages logistics of regional core medical teams, essential document management, meeting logistics and team minutes.
5. Represents AO on relevant global Project Management committees
6. Partners with other TA Project Managers, Affiliate MDs, finance, Metrics & Reporting Manager and Business Operations Manager to ensure accurate data quality, reporting and fiscal oversight.
7. Supports Regional TA and Local MA Teams with budget setting and forecasting of projects.
8. Manages meeting logistics document management, and meeting minutes for Regional MedicalTeams,
9. Identifies risk in projects and agrees on risk management planning in collaboration with MA Teams.
10. Helps to prepare and execute the CMP planning process for MA-AO.
11. To demonstrate personal accountability and fully comply with Astellas Group Code of Conduct and associated policies and procedures and other applicable laws, codes and regulations. Proactively clarify and seek guidance as required, and raise any concerns, in a timely manner, with relevant manager; which may include reference to the Ethics and Compliance Team and/or Ethics and Compliance Helpdesk

Real, a trading division of SThree Pte Limited (Registration Number: 2007.20126E | SThree Pte Limited Licence Number 16S8216 | Real Licence Number 53132073A)

Award winner of:
International Recruitment Company of the Year by Recruitment International 2016

Life Sciences and Healthcare Recruitment Company of the Year by Recruitment International 2016

Best Overseas Operation by Gloabl Recruiters 2017

Application Email: ILYU.08510.3273@sthreesg.aplitrak.com