CASY-MSCCN Jobs

Start-up Strategy Manager

Grade: L2

Hiring Manager: Kentaro Obara, Head of Japan Clinical Operations, R&D

Location: Japan, Tokyo, 50% Remote working

Job type: Permanent

About the job

• The SUSM (Start-up Strategy Manager) will develop strategies to ensure the startup plan is executed to minimize time from study allocation to site activation in compliance with CSU/Cluster timeline predictability, company policies and regulations as well as to prioritize the startup activities according to the clinical plan.

• The SUSM will prioritize the studies start up activities and influence related parties to achieve required performance expectations.

• The SUSM will be involved in from output of the feasibility process and site selection planning, sharing current knowledge to facilitate informed decisions regarding site selection.

• The SUSM will oversee study submissions to competent authorities, Institutional Review Boards/Ethics Committees (IRB/EC) and other review bodies. They will oversee the study contracting and budget activities and preparation of documents for greenlight.

• The SUSM is a key member of the CSU/Cluster study teams, the main contact for the Local Study Manager (LSM), Site Partnership Manager (SPM), and Medical Advisor (MDA).

• The SUSM will drive and report on study start up metrics on behalf of the Country/Cluster Heads and LSM.

Responsibilities

Lead and oversight of the SSU Team members (country or Cluster):

Secure the delivery of the study stat up activities as defined in the study planning tool (Impact), identify opportunities to accelerate, simplify and drive SSU Best in class CMR data.

Provide oversight to the start-up team to ensure study start-up deliverables are met and timelines are optimized.

Oversee management of Health Authority and IRB/EC submissions (start-up and ongoing/amendments).

Manage and communicate the strategic study start-up plan in alignment with the study plan for a global start-up.

Review start-up performance for every study and implement process improvement initiatives as appropriate.

Identify and mitigate risks in startup activities and escalate to the relevant project LSM and CSU Management Team as required.

Coordinate local vendor management activities with LSM and Regional Vendor Lead if needed.

Where necessary support the study team in study start-up-related issues within the country/cluster.

Interface with internal and external stakeholder, maintaining business awareness, contribute to SSU strategy planning.

Connect with key stakeholders and partners; including MDA to integrate study start up activities during the study feasibility process.

Participate in the study handover/kick off meeting from the MDA/SPM to LSM “and respective study team” following country allocation.

Maintain up-to-date knowledge of regulations, laws, and guidelines pertaining to SSU and ensure adherence and compliance to local requirements and associated documentation.

Provide updated information regarding the regulatory and start-up environment to the CSU/Cluster Head,　including trends that could impact approval processes, mainly those related to timelines for approval to study teams, investigators, and site personnel if appropriate.

Maintain oversight of the Global Country Requirements Portal or equivalent and Veeva CTA portal.

As required be the liaison between the CSU and Affiliate/Cluster/Global Regulatory Department for any clinical trial regulatory activity.

Work with the Investigational Product Manager (IPM) regarding IP related timelines, any IP process affecting start up timelines and import/export licenses, if applicable.

Work with the RTM/Trial Operations to secure delivery of any study related material for country start up and planning, as applicable.

Maintain contact with a legal representative as required and have input into legal aspects relevant to study start up activities. Oversee any contract related activity having an impact on startup activities. Close follow up on timelines.

Interface as needed/requested with investigational sites during site start-up activities and for ongoing submissions.

Prepare and complete the Initial LSCR (Local Study Cost Request) and ensure optimization of costs. Update LSCR as required to reflect study evolution during project start up.

Provide oversight, as required of any subsequent revisions of the LSCR during the study conduct phase.

Provide oversight of budget tracking tools and Grant Plan in alignment with corporate requirements.

Contact for Outsourced Studies as required.

Provide to vendor or core team appropriate documentation/templates depending on sponsor/CRO agreement.

Ensure appropriate information for the set-up of outsourced trials be provided as required.

Maintain oversight of outsourced study start up, delivery and maintenance as part of country reporting

Knowledge And Skills

Mandatory

• Knowledge of GCP/ICH phase I-IV clinical trials and observational studies

• Trained for Compliance and Business Integrity

Proficiency Level : Not needed (0), Foundational (1), Intermediate (2), Advanced (3), Game Changing (4)

• Risk Management Skills (2)

• Project Management Skills (3)

• Data Analytics (& Digital) skills (3)

• Medical / Scientific Background -Therapeutic Area / Disease knowledge (2)

• Clinical Development Process Knowledge (2)

• Problem-Solving skills (3)

• Business Acumen (Business Sense) (1)

• Change Management skills (2)

• Emotional Intelligence/good behaviors (3)

• Interpersonal & Relationship Management (2)

• Develop People & Lead Teams (1)

Formal Education And/or Experience Required:

• Bachelor’s degree or higher in Health Science or equivalent depending on the country/Cluster.

• At least 3 Years as a Clinical Research Project Manager or equivalent ideally with at least 2 years of Clinical Trial Start-Up experience.

Knowledge And Skills Desirable but Not Essential:

• Formal training or experience in Project Management

• Experience in the Pharmaceutical Business or related industry

• Broad scientific knowledge across different Therapy Areas

• Experience in working with cross-functional teams

• Knowledge of development in recent technology and how to utilize to optimize outcomes, regulatory, ethical, and legal framework pertaining to study start-up.

Next Career

The potential next career for SUSM is really diverse. SUSM has a lot of opportunity to obtain the basic knowledge and skillset of clinical operation. For example, Local Study Manager, Clinical Innovation, Vender Manager etc.