Study Start Up Specialist/Sr. Study Start Up Specialist

Ergomed; North Carolina; On-site; USD 90,000 - 130,000; Full time

Job summary

Ergomed Group seeks a Study Start Up Specialist to coordinate site activations in line with contracts, trial protocol and ICH-GCP/regulatory requirements. You will lead start-up strategy, drive regulatory deliverables, and act as the primary contact for sponsor and internal teams to ensure timely activation of study sites.

You will review regulatory information, support submissions, manage essential documents, and help mitigate risks while mentoring junior staff and collaborating across

Qualifications

• Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience.
• Minimum 5 years in pharmaceutical/CRO industry.
• Experience managing multi-country start-up projects.

Responsibilities

• Lead study start-up strategy and regulatory deliverables.
• Serve as main contact for all project start-up activities.
• Provide regulatory strategic input and manage risk.
• Prepare and review regulatory submissions for initial authorization and maintenance.
• Coordinate with sites for document collection and ICF/IRB submissions.
• Negotiate contracts with investigative sites per project RACI.
• Assist with feasibility and site identification activities.
• Ensure TMF filing and training and attendance at project meetings.

Skills

Regulatory Coordination

Project Leadership

ICH-GCP Knowledge

Multi-country Management

Documentation Control

Education

Bachelor's in Chemistry or Life Sciences

Tools

MS Office

Job description

Medicine moves forward here. So willyou.

Ergomed is a specialist clinical research organization focused on rarediseaseand select oncology indications. We focus on the most complextrials,the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move promising therapies through early phase development, so they reach the patients sooner.

We choose complex work on purpose. Rare disease and oncology trials carry real operational risk, and our people are experts at reducing it, protecting timelines, dataqualityand the experience of sites and patients at the same time. It is demanding, meaningful work, and no one here forgets that patients cannot wait.

That is why culture matters to us as much as capability. We have built a collaborative, international team where people share ideas, grow theircareersand are trusted to take ownership early. With colleagues across North America, South America, Europe,Asiaand Australia, we value teamwork,flexibilityand a real commitment to work-life balance, because good science comes from people who feel supported.

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 escape 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.

education, qualifications and professional memberships

Bachelor's 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

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world.You’lljoin 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 theoutcome, becausesomeone is waitingonit.

• Agility and responsiveness:we movequickly, becausepatients cannot wait.

• Belonging:everyone is welcome, and every voice counts.

• Collaborative partnerships:we go further by going together.

U.S. Hiring Locations:

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