Parexel FSP has an exciting opportunity in Site Start Up! The Associate Manager, Site Start Up will have responsibilities for the creation and management of Site information within the CTMS system, including but not limited to Institution, relevant Personnel and related tasks/activities/deliverables associated with tracking Site Activation. Serves as the primary contact for creation and management of the Investigator and Institution Global Directory.
Will play a leading role in ensuring the assembly and distribution of Site Administrative Binders to investigator sites at the time of site initiation/activation.

JOB DUTIES:

Investigator/Institution Global Directory
•    Captures relevant information to create investigator/institution entities within the CTMS system to then enable site association with a clinical trial; routinely reconciles unique identifiers to ensure adherence to Sponsor requirements in addition to the alignment of industry/CRO related Identifiers
•    Gathers, tracks and reports on the status of Site Creation and Site Selection to ensure that all required study identifiers have been assigned and communicated as needed to promote alignment across standalone systems and repositories
•    May track the receipt of site generated documents (completed/signed forms, etc.) for the purposes of achieving Site Activation status for all identified and selected investigator sites
•    Assesses legibility/reproducibility and integrity/fidelity of documentation and ensures compliance to ICH/GCP and Sponsor requirements regarding Essential Documents
•    Enables the tracking of Site Initiation and Activation status for all selected investigator sites and may register key essential documents into the Trial Master File; Captures relevant study, country and site level information and milestones within the CTMS system
•    May track Site Training Documentation to ensure that Investigator site staff are appropriately trained on GCP/ICH guidelines, patient data capture requirements, Safety Letter distribution and other protocol specific requirements that may be defined by the clinical study team
•    Supports the identification of Investigator Meeting attendees (Site staff and Clinical Study team members) and ensures attendance
•    Enables tracking of Site Activation status for all selected investigator sites and may register key essential documents into the Trial Master File

JOB REQUIREMENTS

•    Working knowledge of the clinical drug development process, ICH/GCP and regulatory guidelines/directives
•    Demonstrates ability to prioritize and manage multiple projects simultaneously
•    Demonstrates effective problem solving and decision-making skills
•    Interpersonal, collaboration and stakeholder management skills, Good communication (written/verbal)
•    Highly organized, detail oriented
•    Ability to synthesize information and demonstrate strategic thinking
•    Self-motivated, flexible, able to follow through in a fast-paced environment, ability to meet deadlines under pressure
•    Computer skills with competency in MS suite, CTMS, eTMF; Veeva a plus

EDUCATION REQUIREMENTS

Bachelor’s degree and minimum 1-3 years of relevant/clinical essential document review experience.