Do you want to watch clinical development change, or do you want to be the one to shape it?
Because we’re hoping you’re here for the latter.
We Are PRA.
We are 16,000+ employees strong, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do.
Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.
Who are you?
You are a confident leader who is always on the move. You believe the most successful projects are accomplished through teamwork and dedication and you know how to inspire the best out of those around you.
You’re passionate about your work. You have a keen eye and pay attention to detail. Quality is everything to you and so you are relentless about ensuring the data is clean.
You are able to manage multiple competing priorities at once. You are deliberate in your communication with internal and external clients and you feel invigorated by a fast-paced environment in which things are always growing and changing.
Still here? Good. Because if this is you, we’d really like to meet you.
What will you be doing?
As a Lead Data Manager (LDM) you are responsible for the successful delivery of Data Management deliverables meeting internal and external client needs.
In addition, you also contribute to Business Development efforts within Data Management.
You serve as the primary client liaison for Data Management issues. So, a typical day in this role could include tracking milestones, tasks, and overall budget for assigned projects;
ensuring timely completion of all project status reporting; interfacing with internal team members across all departments;
developing a plan and overseeing timelines for activities between the last patient’s last visit and database lock; providing study specific training as appropriate;
ensuring customer requirements are accurately captured; reviewing Data Management Plans for content and structure; providing case report form design oversight;
ensuring quality control steps are properly planned and completed on all studies.
What do you need to have?
Undergraduate degree in Allied Health, Bio-Medical, Clinical Informatics, or a related field desired, but not required.
At least 2 years of experience working for a CRO, within the last 5 years desired.
Leadership experience, specifically as the primary point of contact for a Clinical Data Management project team.
Lead experience managing at least 3 studies simultaneously.
Experience with all steps within the Data Management lifecycle and most major Data Management study tasks, with proficiency in at least one Clinical Data Management system required.
Familiarity with Rave is desired.
Budget experience is desired.
Project management experience is required. Must have experience managing timelines.
Vendor management or third-party management experience is required.
Proven history of successful interaction with internal and external clients and an understanding of related functions.
Bid defense experience, local lab experience, SDTM and Data Programming experience desired. But, not required.
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.