Temp - Associate Manager, Global Study Start-up
The Associate Manager, Global Study 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. This role will serve as the primary contact for creation and management of the Investigator and Institution Global Directory and 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.Investigator/Institution Global Directory
- Collects relevant information to build 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 supervise 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 crucial documents into the Trial Master File; Collects relevant study, country and site level information and landmarks 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 the tracking of Site Activation status for all selected investigator sites and may register key essential documents into the Trial Master File
Bachelor’s degree and minimum 1-3 years of relevant/clinical essential document review experience.
- Working knowledge of the clinical drug development process, ICH/GCP and regulatory guidelines/directives
- Ability to prioritize and handle multiple projects simultaneously
- Demonstrates effective problem solving and decision-making skills
- Interpersonal, teamwork and partner management skills, Good communication (written/verbal)
- Highly organized, detail oriented
- Ability to synthesize information and demonstrate critical thinking
- Self-motivated, flexible, able to follow through in a fast-paced environment, ability to meet deadlines under pressure
- Computer skills with proficiency in MS suite, CTMS, eTMF; Veeva a plus
- May require up to 25% travel
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.