Trial Disclosure Associate I

Tellus Solutions is in partnership with a committed biopharmaceutical company focused on providing innovative therapies. Your technical expertise as a Trial Disclosure Associate I in the area of clinical trial registries, regulatory agency transparency or drug development to our client's innovative therapies which will impact the quality and duration of life.
Job Description:

• The Trial Disclosure Associate will be responsible for a variety of activities including but not limited to, study Registration/ Results Postings, Agency Disclosure activities, companywide Redaction/ Anonymization of clinical documents for public disclosure and Access To Data processes.

Responsibilities:

• Works closely with/support the Senior Associate, Trial Disclosure, CTD and Manager(s) of TD: to determine the Client drug trials required to be registered and results disclosed, to effectively communicate this information and related timelines to the applicable individuals involved in these activities, to provide guidance to and build cross-functional collaborative relationships, to coordinate the completion of these activities to achieve/ensure timely disclosure of accurate Works closely with/support the Senior Associate, Trial Disclosure, CTD and Manager(s) of TD: to provide writing support for global study registrations/results postings and amendment, support global registration updates and administrative needs, and monitoring milestone compliance and to provide support for company wide Redaction/Anonymization of clinical documents for public disclosure and Access To Data processes.
• Works closely with/support the Senior Associate, Trial Disclosure, and Manager(s) of TD in operationalizing changes in both the US and International regulatory environment via participation in the development and implementation of SOPs/processes as well as creates efficiency improvements/furthers system automation and related communication and training activities. Identifies issues and escalates appropriately Participates in TD compliance prevention by providing QC checks and metrics as requested.
• Cross-trains with other Trial Disclosure staff. Accountable for meeting the main objectives of assigned projects/roles and responsibilities within established timelines and with an appropriate quality level. Daily interaction with Trial Disclosure Associate II and/or Manager(s) of TD as well as significant interface/communication with cross-functional areas.

Qualifications:

• Bachelor degree (BA/BS) from an accredited college or university is required, preferably in a health or biological science fi eld.
• Must have 2+ years of experience in clinical trial registries, regulatory agency transparency or experience in a related area such as quality or regulatory and working knowledge of drug development.
• Must be familiar with ICH and GCP Guidelines and have good organizational and communication skills and competent in application of standard business procedures (SOPs/Work Instructions, OEC).
• Must have the ability to prioritize role sand responsibilities daily and work well under deadline pressure in a team environment in order to execute goals to ensure they are achieved (i.e. maximizes individual skills utilizing the collective skills of the CTD area).
• Comfortable working in Excel, Word and open to learning new systems