At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https: //www.jnj.com

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

Clinical Trial Support Intern

Location: Sofia

Duration: 12 months

Sector: Pharma

Type: part-time (20hours/week)

Study Planning Activities

Site Identification: Support the local study team in performing country and site feasibility

Trial documentation: Support the preparation of study files and of any other document required pre-trial.

Study Start Up Activities / Site start-up

Help the Clinical Trial assistant in ensuring that the current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site.

Support the Local trial manager (LTM) and the Clinical Trial assistant (CTA) Health Authorities Submissions.

Help the Site Manager (SM) and the CTA in obtaining site related trial documents.

Support the CTA in collecting and processing as appropriate the IFDF and related documents throughout the trial.

Assist the LTM in conducting local investigator meeting or in making arrangements for the investigators participating in an international meeting as applicable

Help in the distribution, collection, reviewing, and tracking of regulatory documents, start-up documentation from sites, agreements and training documentation.

Study Execution Activities

Support the CTA and SM in ensuring that during the trial all relevant trial related documentation is provided to investigators) within the timelines.

Support the CTA in maintaining the study files.

Provide administrative and logistic support to the LTM and the Management team in tracking of progress of the trial, management of study data, budget, organizing meetings, mailing and correspondence and other relevant tasks as appropriate, where applicable

Support the CTA in up-loading documents into vTMF

Support the CTA and SM in set-up new study site team members in CTMS

Support SM in study medication accountability at site under SM supervision. SM is accountable for the whole task, and all ensure that all confidentiality and data privacy rules are followed

Additional supportive tasks related to study management can be assigned depending on the ongoing projects

Requirements:

A minimum of a Bc. Degree in Life Science or three years of University in Life Science

Strong knowledge with MS office (Word, Excel, Outlook)

Strong interpersonal skills

Organizational skills and the ability to collaborate and handle multiple priorities within matrix environment

Ability to perform activities in timely and accurate manner

Advanced English

Good written and oral communication