Parexel FSP is looking for a Study Start Up Manager in the United States.

This is a remote role. Oncology experience required. Cell Therapy strongly preferred.

Job Purpose:
The Study Start-Up Manager (SSU Manager) is responsible at country level for managing and conducting start-up activities in compliance with the Client procedures, documents, local and international guidelines such as ICH – GCP and relevant regulations.
The SSU Manager will prepare, review, track and manage site regulatory documentation at country and site level, and will maintain, review and report on site performance metrics.
The SSU Manager works in close collaboration with the Clinical Research Associates (CRA) and the Local Study Team (LSD)/Local Study Associate Director (LSAD) to ensure that study start-up activities and milestones are achieved in a timely and efficient manner.

Key Accountabilities:

Trial and site administration
• Contribute to ensure that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Actively participates in Local Study Team (LST) meetings.
• Provide regular information to Line Managers at country level on study and planned study milestones/key issues during the start-up period.
• Provide feedback on any research related information including sites/investigators/competing studies that might be useful for the local
market.
• Support Study Management and Monitoring (SMM) in different initiatives (local, regional or global) as agreed with the SMM Line Management.
• Upon local decision, may support site selection process by identifying and assessing potential sites/investigators.

Document management
• Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Support Quality Control (QC) checks performed by LSAD or delegate to ensure that all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enroll, and in line with Client SOPs.

Regulatory and site Start Up responsibilities
• Accountable for study start-up and regulatory maintenance being in charge with collection, preparation, review and tracking of documents for the application process.
• Accountable for submission of proper application/documents to Regulatory Authorities and/or IEC/IRB during start-up period.
• Update CTMS and other systems with data from study sites as per required timelines during the start-up period.
• Follow up on outstanding actions with study sites during start-up period to ensure resolution in a timely manner.
• Upon local decision, may be accountable for continuing submission of proper application/documents to IEC/IRB and to Regulatory Authorities for the duration of the study.

Budgeting, Agreements and Payments
• Upon local decision, may be accountable for preparation, review and
negotiation of contracts with investigational sites being the primary point of contact for investigational sites to ensure the contracts are fully executed.
• Upon local decision, may assist in initial forecasting for budget, study
materials and drug supplies. Plan applicable local drug activities (local purchase or reimbursement).

Compliance with Sponsor Standards
• Ensures compliance with Client’s Code of Ethics and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
• Completes timesheets accurately as required.

Compliance with Parexel Standards
• Complies with required training curriculum.
• Completes timesheets accurately as required.
• Submits expense reports as required.
• Updates CV as required.
• Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.

Skills (Essential):
• Good collaboration and interpersonal skills.
• Good verbal and written communication skills.
• Excellent attention to details.
• Good negotiation skills.
• Good ability to learn and to adapt to work with IT systems.
• Proficient in written and spoken English language required.
• Fluency in local language(s) required.

Skills (Desirable):
• Integrity and high ethical standards.

• Good analytical and problem-solving skills.
• Good financial management skills.
• Basic change management skills.
• Good intercultural awareness.
• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
• Good analytical and problem-solving skills.
• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.

• Good cultural awareness.
• Team oriented and flexible; ability to respond quickly to shifting demands and
opportunities.

Knowledge and Experience (Essential):
• Good knowledge of international guidelines ICH-GCP as well as relevant local
regulations, basic knowledge of GMP/GDP.
• Basic understanding of drug development process.
• Excellent understanding of Clinical Study Management and study start-up.

Knowledge and Experience (Desirable):
• Good medical knowledge and ability to learn relevant Client Therapeutic Areas

Education:
• Bachelor’s degree in related discipline, preferably in life science, or equivalent
qualification.

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