Project Manager (Clinical Trials)

Technical Project Manager- Clinical Trials Data and BiostatsCandidate will be working on 2 different projects-NEED someone who understands clinical trials data-NEED someone who understands biostatsProject 1:Building custom apps that we will get from clinical trials data to build of data visualization using snowflakeProject 2:Upgrading SAS from 9.4 to 9.6Need to know how premising and group policy work.They are in the process of standing up a new server and migrating the data over.PM will be working on migration timeline

The candidate will be responsible for leading integration efforts to collect data from relevant vendors/sources by evaluating, analyzing data, and defining data connection approach. He/she will work with internal and external (data engineering) teams to translate

requirements for a successful configuration. Candidate may also be responsible for creating/modifying SOPs (Standard Operating Procedures) and work instructions.

The candidate will also be the point of contact for the Clinical Data project and SAS platform to enable effectiveness and productivity of teams in the rapidly changing clinical development world.

The ability to work with some ambiguity is a plus. The successful candidate will help create and develop data connection needs and any SAS support needs.

This candidate will need to excel in vendor management and execute at an individual level. In addition, project manage and lead parallel initiatives where needed. (e.g., new SAS functionality, modify/create dashboards) The candidate will require a blend of technical expertise, strategic planning, and leadership to successfully deliver project objectives.

Successful candidates will possess a fun, flexible, roll up your sleeves attitude, with the ability to work independently and enjoy working in a dynamic, fast-paced environment during a period of significant growth.

Responsibilities (including, but not limited to):

Responsible for supporting the day-to-day interactions with internal and external clinical teams.Facilitate and lead business process and / or design sessions with the business and technical teams to identify functional and technical

requirements.Work with project leadership to track issues, mitigate risk, document, and communicate appropriately to proactively reduce the impact of scope creep and drive issues to resolution.Monitor progress, aid with test scripts, coordinate User Acceptance Testing and implementation of various updates in Veeva through formal change control.Ensure source system changes are accurately reflected in our Analytical reporting and integration points.· Identify key areas for end user

education and partner internally to develop and execute.

· Generate/Aid SOPs, where appropriate, to keep IT processes up to date.

· Proactively identifies and communicates system changes and updates to affected parties in advance.

Qualifications

· Bachelor/master's degree in life science, data science or related field.

· Proven project management

skills (5+ years) including the ability to lead in an environment with multiple partners, vendors, and competing priorities.

· Strong problem-solving

skills and ability to adapt to changing project

requirements.

· Proficient in clinical data (EDC (Electronic Data Capture), IRT (Interactive Response Technology), and other relevant sources).

· Effective communication and interpersonal

skills, with ability to work with diverse teams and stakeholders.

· Extensive

experience in clinical data management with a strong understanding of clinical trial processes, GCP and relevant regulatory and quality guidelines.

· 2+ years of

experience working with Tableau and solid understanding of how reports are consumed.

· Strong familiarity cloud database platforms with solid understanding of SQL (Snowflake preferred)

· Strong familiarity with source systems (e.g., Medidata/EDC, IRT) and how data is sourced and stored.

·

Experience leading projects with multiple stakeholders (e.g., Clinical and Biometrics)