Study Start Up Specialist

Job Description

Job Title

Study Start-up Specialist (SSUS)

Location(Field/HO)

HO

Functional Reporting

Associate Director, Clinical Operations

Work Level

WL 5A

Operational Reporting

Associate Director, Clinical Operations

Function

Medical (Clinical Operations)

People Manager (Y/N)

No

Role Summary

The Study Start-Up Specialist (SSUS) is responsible for

How does the role serve the patients?

Providing early access to innovative treatment to patients across the country by:

• Guiding HCP and HCO development for participation in Roche sponsored studies.
• Facilitating early regulatory approvals to ensure optimal efficiency in start-up timelines.

Accountabilities

Study Start-up Coordination and Execution:

• Coordinate and assist with all start up activities prior to site activation, including but not limited to:
  • Site Informed Consent Form (ICF) localization and guidance in line with regulatory/health authority requirements
  • Ethics Committee information, meeting dates & costs
  • Ethics Committee applications & associated online systems
  • Ethics & Governance submission processes
  • Clinical Trial Health Authority application and regulatory submission process
  • Contracts & Insurance request process
  • For global studies, localize global Informed Consent Form (ICF) with country requirements
• Maintain up-to-date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation.
• Support Clinical Operations Head in Reviewing, analyzing and collating metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up and contracts negotiation.
• Ensure all start up information & requirements are kept up to date in a central repository for both global and local Study teams.
• Assist with label preparation and approval (local label representative) for studies in collaboration with local regulatory department.
• Support Clinical Operations Head in Tracking metrics and study start-up timelines to identify trends and opportunities for improvement.
• Prepare all study plans as required by the Roche Reference Model/ Applicable Roche SOPs and finalize the plans in conjunction with CSM/ CSS/ Other internal stakeholders/ Vendors prior to first patient enroll

Relationship Management:

• Support Clinical Operations Head in Liaising and collaborating with relevant authorities / bodies to further enhance clinical trial processes, government policies / laws, via innovative approaches.
• Updates knowledge on changes in Start Up processes across government, hospital & industry and liaise with stakeholders to resolve any SSU issues.
• Support Clinical Operations Head in proactively responding to information survey requests by government / industry bodies.
• Provide continuous and proactive communication with ECs / hospital administration / industry bodies to obtain accurate and up-to-date information on clinical trial status and activities.
• Maintain communication with local legal/regulatory/medical affairs departments to ensure input is sought and all internal/external requirements are met.
• Assist CSMs and CSS on regulatory/ethics, track & drive site activations by regular review and monitoring status of submissions/activations.
• In collaboration with vendor management and procurement, support Clinical Operations Head in providing inputs as required into vendor identification, selection, and RFI/RFP process.
• Liaise and share best practices with other SSUS within the region/organization.

New Site Identification:

• Assist with identification and tracking of new sites in collaboration with CSMs.
• Negotiate contracts and study budgets with sites during the study start-up phase to ensure finalization.
• Provide local fee structures and budgetary advice as required and ensure compliance to Fair Market Value (FMV) in the country.
• Collaborate with CSMs to maintain data to ensure FMV.
• Liaise with Study Managers to implement budget cost containment and implement contingencies as required

Internal Stakeholders

Medical, Business Insights & Sustainable Value, Legal, Communication, Value Teams (Oncology & Specialty), People & Culture

External Stakeholders

Roche Global & Regional Medical Teams, HCPs and HCOs, Regulatory authorities, Industry Bodies, Patient Support Groups, Vendors

Functional Competencies

Knowledge of ICH-GCP, Indian Regulations, multiple therapy area knowledge, technical expertise in the field of clinical operation, vendor management

Behavioral Competencies

Exhibition of Roche Core Values, Exhibition of Servant Leadership, Patient centricity in decision making, Strong Collaboration and Networking skills, Inspiring and Influencing

Eligibility Criteria (Qualification and Experience)

• University Degree or Equivalent preferably in a medical/science-related field. Higher degree and / or specialist accreditation desirable
• Employee has completed minimum 1 yearwith Roche Pharma (Applicable for internal hire)
• Employee having an overall experience of minimum 2 years in Pharmaceutical / Biotech / Clinical Research industry with minimum 1 year experience in the Clinical Research Industry
• .Job Location: Mumbai (HO)
• Willingness to travel domestically and internationally, as required
• Willingness to relocate

Roche Leadership Commitments (RLCs)

Roche Core Competencies (RCC)

1. I take a genuine interest in people.

2. I listen carefully, tell the truth, and explain "the why".

3. I empower and trust people to make decisions.

4. I discover and develop the potential in people.

5. I strive for excellence and extraordinary results.

6. I set priorities and simplify work.

7. I congratulate people for a job well done.

Strategic Agility,Decision Making, Technical and Business Expertise, Communication, Managing Change, Inspiring and Influencing, Teamwork and Collaboration, Achieving Results, Feedback and Coaching, Innovation