Study Start Up SpecialistSr. Study Start Up Specialist

Study Start Up Specialist coordinates and oversees all activities related to achieving the goal of site activations in accordance with the contract trial protocol and other study specific requirements ICH-GCP all applicable SOPs and regulatory requirements. Study Start Up Specialist takes leadership and acts as the primary point of contact for Sponsor and internal stakeholders during the study start-up process. 

Role and Responsibilities

• Assume leadership during study Set-up process ensuring development of start up strategy effective and rapid coordination and management of regulatory deliverables driving the team to meet the agreed targets and to comply with the agreed procedures trackers and templates.
• Serve as main point of contact for all project-specific Study Start-Up activities.
• Provide regulatory strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures. Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures.
• Prepare collect review regulatory information to support regulatory submissions for initial authorization and maintenance in compliance with all applicable regulations.
• Collect review for completeness and compliance and track essential documents for Study Start-Up to facilitate efficient site initiation and activation. Investigate incomplete inaccurate or missing documents to ensure accuracy and completeness of information. Prepare study team reports or updates regarding status of essential document collection review and approval.
• Actively correspond with selected sites for updates regarding essential document completion Informed Consent Form (ICF) development on site level (if applicable) and Institutional Review Board (IRB)/Independent Ethics Committee (IEC) submissions/approvals.
• Coordinate with study teams sponsors clinical monitoring clinical contracts and/or other functional areas on the priority and processing of documents leading to investigational product release site activation and site initiation.
• Take ownership in contract negotiations with investigative sites or coordinate other team members assigned to perform contract negotiations as per study specific RACI (Note: activity supported by other team members as per study contract or study specific RACI; e.g. Legal CTM Monitor etc.). 
• Assist with feasibility and site identification activities as needed.
• Arrange for and/or review translation of essential documents as required.
• Attend project team meetings and training sessions according to project and/or Sponsor requirements.
• Ensure all relevant documents are submitted to Trial Master File (TMF) for filing as per study specific guidance.
• Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated monitor project budgets hours spent vs budgeted and promptly identify and escalate any OoS.
• Support mentor and train department staff and new-hires.
• Provide support to proposal development and input to budgets provide department representation to BD meetings as required.
• Assist with development and implementation of trainings and SOPS/practice improvements.

Qualifications :

education qualifications and professional memberships

Bachelors Degree in Chemistry or Life Sciences Nursing or equivalent experience

EXPERIENCE

• Minimum 5 years within pharmaceutical/CRO industry
• Proven ability to successfully manage multi-country projects in start-up

SPECIAL SKILLS

• Excellent organizational and management skills
• Strong planning strategizing managing progress monitoring scheduling problem-solving and critiquing skills
• Good interpersonal skills in a fast-paced deadline oriented and changing environment
• Excellent self-motivation and motivation skills
• Outstanding knowledge of ICH GCP across all areas
• LANGUAGE SKILLS

  English both oral and writing

• PC SKILLS

  Proficiency in all MS-Office applications including Microsoft Word Excel and PowerPoint

Additional Information :

When you join Ergomed Group you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. Youll join a passionate and collaborative team of experts in clinical research pharmacovigilance and quality consulting.  

We are diverse in many ways yet our values unite us. Our values are how we work not words on a wall. If they sound like you you will feel at home here. 

• Quality: we hold ourselves to the standard patients deserve. 

• Integrity and trust: we do the right thing especially when it is hard. 

• Drive and passion: we care about the outcome because someone is waiting on it. 

• Agility and responsiveness: we move quickly because patients cannot wait. 

• Belonging: everyone is welcome and every voice counts. 

• Collaborative partnerships: we go further by going together. 

We look forward to welcoming your application. 

U.S. Hiring Locations:

Florida Georgia South Carolina North Carolina Virginia New York Tennessee Texas Ohio 

#LI remote

Remote Work :

Yes

Employment Type :

Full-time