Study Start Up Specialist, Senior

🔥 0 minutes ago

🇷🇸 Serbia – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 16%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Lead and coordinate the study set-up process, including development of start-up strategy • Coordinate and manage regulatory deliverables to meet agreed targets and procedures • Serve as the main point of contact for project-specific Study Start-Up activities • Provide regulatory strategic input and identify and address risks • Prepare, collect, review, and track regulatory information and essential documents for submissions, site initiation, and site activation • Investigate incomplete, inaccurate, or missing documents • Prepare study team reports and status updates • Correspond with selected sites regarding document completion, ICF development, and IRB/IEC submissions and approvals • Coordinate with study teams, sponsors, clinical monitoring, contracts, and other functions on documents leading to investigational product release, site activation, and site initiation • Own or coordinate investigative-site contract negotiations • Assist with feasibility and site identification activities • Arrange or review translations of essential documents • Attend project meetings and training sessions • Ensure relevant documents are filed in the Trial Master File • Monitor departmental deliverables, project budgets, hours, and out-of-scope work; escalate issues • Support, mentor, and train department staff and new hires • Support proposal development, budgets, and business development meetings • Assist with training and SOP/practice improvements

🎯 Requirements

• Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent experience • Minimum 5 years within pharmaceutical/CRO industry • Proven ability to successfully manage multi-country projects in start-up • 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 • English both oral and writing • Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint

🏖️ Benefits

• Full-time employment • Collaborative, international team • Flexible work environment • Work-life balance • Career growth opportunities • Supportive team culture • Opportunity to make an impact on clinical research and patient care