• Responsible for the independent preparation, review and approval of country related submission packages in accordance with ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards – within specific timelines and quality standards;

• Responsible for the independent preparation, review and approval of site level critical documents for Investigational Product (IP) release in accordance with regulatory/sponsor requirements – within specific timelines and quality standards;

• Develop and finalize Master and Country Specific Information Sheets/Informed Consent Forms (SIS/ICFs).

• Recognize, exemplify and adhere to DOCS’ values which center around our commitment to People, Clients and Performance;

• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs;

• *Travel (approximately 15%) domestic and/or international. Anticipated activities may include attendance at Kick-Off, Investigator or study team meetings

• *Perform feasibility, site identification, site contract negotiation, and other study start up activities, as assigned;

• *Prepare, review and submit submissions to CA, EC and other relevant authorities in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct;

• This includes, but it is not limited to:

o ethics/regulatory/other relevant authority approvals for clinical trials;

o ethics/regulatory/other relevant authority approvals for trial amendments;

o ethics/regulatory/other relevant authority study notifications;

o authorizations for import/export of investigational products, clinical supplies and biological samples;

o approvals from the national authorities for data protection.

• *Review and translate Drug Labels;

• *Advise Sponsor on knowledge content for development of Drug Labels;

• *Perform independent quality review of submission packages;

• *Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA) and Ethics Committee (EC) submission information, and similar information for other related organizations, for the assigned countries and update relevant DOCS information system;

• *Responsible for the translation and co-ordination of translations for documents required for submission;

• *Perform timely and accurate data entry of regulatory documents, submission status and maintenance of Country/Investigator information in the appropriate clinical trial management system;

• *Copy and route incoming correspondence, internal documentation, etc., as appropriate;

• *Responsible for the timely follow-up for queries made by EC/CA;

• *Responsible for the collection of critical documents required for IP Release;

• *Attend study team meetings as required (maybe discretionary), including Kick-Off Meetings which are mandatory;

• Assemble and distribute study materials to Clinical and Project teams, including materials to study sites and Investigator Meetings (e.g.; investigator binders) and vendors, as appropriate;

• *To be familiar with ICH GCP, relevant country regulations/guidelines and DOCS SOPs;

• Competent in communication skills for timely follow-up, issue resolution and report updates; as outlined in the communication and escalation plan with timely documentation;

• To undertake other reasonably related duties as may be assigned from time to time.

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation maybe made to enable individuals with disabilities to perform the essential functions;

Education / Qualifications:

University/Maater degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)

Experience:

Minimum 0 – 2 + years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job

Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines. Demonstrated basic understanding of the clinical trial process