Clinical Trial Manager/Senior Clinical Trial Manager (FSP)

Key Accountabilities:

Leads the local/regional trial team in the capacity of R/OPU Clinical Trial Manager (CTM)

Trial Preparation, Conduct and Closeout:

1. Selected sites conduct and deliver the trial according to the clinical trial protocol, within trial timelines, and in compliance with ICH-GCP and all other relevant external regulations.

2. Lead and support local trial team and investigative sites in timely preparation of required trial documents, contracts and necessary approvals.

3. All Regulatory Requirements are satisfied prior to trial/site initiation.

4. Where necessary, set up and manage external suppliers that meet requirements of local/regional trial operations.

5. Set up, manage and review R/OPU trial budget to ensure appropriate level of financial oversight. Timely budget updates based on trial changes.

6. Ensure appropriate trial-specific training of R/OPU internal and external partners in line with Trial Training Plan

7. In collaboration with Site Monitoring Lead and CRAs, ensure

- provision of appropriate trial oversight for the trials by monitoring compliance of trial sites and client team to GCP, local regulations, client SOPs (for client staff and issue), and adherence to trial protocol.

- adequate trial supply distribution to sites.

-continuous and timely data entry and cleaning, and on time Data Base Lock.

8. Trial contact for CRAs, investigators and site staff.

9. In collaboration with Trial Resource Specialist and with supports from CRAs as appropriate, ensures collection of required documents, with timely, complete and compliant archiving of all relevant documents for the eTMF and CTR Appendices.

Management and Relationship Responsibilities

Develop and maintain company relationships with external experts and investigational sites by coordinating and ensuring cross-functional collaboration amongst Clinical Operations and Medical

Affairs on Regional/ local level, and supporting CRAs in site contacts.

Collaborates with other BI functions to support Trial Management topics and support integration across Medicine.

Participate in working groups related to Trial Management, represent trial on local and regional level, providing updates on trial within R/OPU.

Regulatory and I or Organisational Requirements

• Ensures all tasks are carried out in accordance with respective applicable Client SOPs, Client Business Practices and regulatory requirements. Ensures that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with Client Values.
• Leads local trial team to ensure integrity of trial conduct, assurance of patient safety, and that local/regional component of trial is planned, conducted and reported in line with regulatory requirements. Requires orchestration of local trial team, and integration with other functions as necessary throughout planning, conduct and closeout of trial.
• Works within a complex GCP and regulatory environment and on global clinical trials with multidisciplinary, international teams and with various internal and external stakeholders including suppliers and investigational sites. Represents the company for the function at internal and external meetings, e.g. with investigational sites or regulatory agencies/inspectors. Failure can have impact on project deliverables (e.g. timelines, costs, integrity of trial data), the reputation of Client with stakeholders and regulatory agencies. More than one assignment in parallel requires balancing conflicting priorities. Is involved in design and implementation of new innovative method as working group member.

Knowledge and Experience:

• 5-8 years of relevant experience in the clinical research field with 1-5 years of experience in clinical project management

• Adapts communication style to audience to effectively influence stakeholders.

• Demonstrates active listening skills and cultural awareness.

• Scientific and Operational Expertise: Demonstrates scientific knowledge and operational expertise across all aspects of clinical trial execution ie start-up, conduct and reporting. Dimensions of trial complexity include protocol phase and indication, # patients, # sites, # countries, # vendors.

• Leadership and Influence: Inspires team to achieve a common goal. Translate complex situations to actionable parts. Anticipate and resolve challenges through effective influencing of cross functional team members and management

• Strategic Mindset: Anticipates future trends and needs and translate them into strategies that fits the overall TA portfolio and the ambition and values of Clie . Contributes to cross functional initiatives within and beyond medicine.

• Project Management: Plans, sets priorities, defines actions, makes effective use of resources, proactively strives for clarity to accomplish the business deliverables

Education:

• University degree in life sciences or related field, higher degree/qualification preferred (e.g. MSc, PhD).