Sr. Clinical Documentation Specialist

Location
San Francisco, CA, United States
Posted
Nov 03, 2018
Ref
3390-530-2018
Hotbed
Biotech Bay
Required Education
High School or equivalent
Position Type
Full time
Position Overview

The successful Sr. Clinical Doc Specialist candidate shall contribute to and support the company's Research and Development (R&D) efforts to establish high value therapeutics to address unmet medical needs.

This position shall provide the following roles and responsibilities within the Development Operations Functional Area:

Assist with the coordination of documentation associated with conducting clinical studies, including but not limited to management of the Trial Master File (TMF) documents. Management of the process in conjunction with the clinical study teams to develop, approve, post, and revise clinical trial registry postings (e.g. ClinicalTrials.gov). Support the development of standardized clinical trial tools and controlled procedures, such as Standard Operating Procedures (SOPs) and Work Instructions (WIs). May be responsible to serve as a resource during internal or external audits as well as health authority inspections. Serve as key central contact to clinical study teams for communications, correspondence and associated documentation relating to Clinical Trial activity. Management of the exchange of TMF documents with external service providers such as CROs and Central Laboratories. Maintain document Quality Review schedule and perform periodic inventories of study/project TMFs ensuring a state of Inspection Readiness. Assists with off-site archiving activities (including budget, cataloguing process, and document retrieval). Support other clinical-study projects as assigned. May provide guidance to junior and/or staff.

Requirements:

Ability to complete tasks in creative and effective ways. Works on assignments requiring considerable judgment and initiative. Understands implications of work and makes recommendations for solutions. Requires a minimum of a High School diploma, (an Associate degree is a preference). Equivalent experience may be accepted. Typically 6 years industry experience working in the Pharmaceutical, Biotechnology or other related industry is required. Strong attention to detail is required. Good communication skills both oral and written are a must. Good computer skills are required. Working knowledge of MS Word, Excel, and PowerPoint is required. Excellent organizational skills are required. Must have an ability to multi-task.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.