天津招聘

职位描述：
Responsibilities:

Working fully insourced to and based at the offices of our global pharmaceutical client, the Study Data Manager is responsible for the following:
 
Data Management Experience / Experience in Drug Development Processes:
Solid understanding of the drug development processes
Significant experience in using data management methodologies and technologies
Proven experience in data management processes from study start to clean database declaration, incl. experience in collaboration with other functions involved in study processes (e.g., StM, Medical, EDC development, Statistics, Medical Writing)
Proven ability to read and understand Clinical Study Protocols, Statistical Analysis Plans and Medical Review Plans, and to create data management specifications (e.g., CRF, Meta Data, Protocol Deviation Documents, Edit Check Specifications) based on these documents
Good understanding of regulations and guidelines (e.g. ICH, GCP)
 
Personal skills (Language, IT, Self- and Project-Management):
Proven effective self-management and organizational skills, ability to work self-organized and independently
Good project management skills
Solid experience as player in global, cross functional teams, including ability to lead such teams towards a given goal (e.g., goals like “DM ready for FPFV”, “Timely Clean Database Declaration”)
Strong written and oral communication skills in local language and English (fluent speaking mandatory), incl. a broad experience of developing and delivering presentations and publications in English
Solid understanding of IT processes and databases used in Clinical Development
Willingness to learn and further develop personal skills
 
Performing Study Data Management tasks
Assume operational responsibility for Study Data Management (SDM) related tasks
Document all activities adequately in the course of the study
Specify and / or develop study specific data components (study metadata), interact with the EDC developer in the specification and design of eCRFs and database structures
Specify study specific data consistency checks (edit checks) in the Data Validation Document
Contribute to the DM part of EDC UAT
Perform consistency check for external data
Request and coordinate the SAS-programming of edit checks and derivations
Identify and issue queries, incorporate query replies, track query status
Contribute to the preparation of data monitoring
Prepare data listings or data extracts for medical reviews and reports specifically
Provide the protocol deviation document for all assigned studies in cooperation with the study team
Prepare a database closure plan, communicate plan within the study team, conduct the database-closure activities
Identification and communication of issues which have the potential to affect timelines or data


Requirements:
The successful candidate for this role should have the following qualifications:
 
Bachelor’s degree (or equivalent) in Natural Sciences, Informatics or Medical Documentation
3+ years of experience as Study Data Manager in projects and study teams, with a comparable area of responsibility as requested in this SSD
 
Minimum basic fluency in English (ability to read, write and listen) is an absolute requirement, as well as an ability to communicate effectively with others and manage your time effectively.


Overview:

As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.
 
At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.
 
At PRA, borders do not create boundaries. PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities. 举报 分享

Headline:
Do you want to watch clinical development change, or do you want to be the one to shape it?

Sub-head:
Because we’re hoping you’re here for the latter.

Body Copy:
Who are we?
We Are PRA.

We are 11,000+ employees strong, operating in more than 85 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 are getting live saving drugs into the hands those who need them most.

Who are you?
You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Clinical Research Associate, you want to change the future. You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.

Still here? Good. Because if this is you, we’d really like to meet you.

Also, we have sign on bonus opportunities up to $15,000 which are pretty cool too.

What will you be doing?
As a Clinical Research Associate (CRA), you will monitor the progress of clinical studies, either at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
What do you need to have?
?    Undergraduate degree or its international equivalent in clinical, science, or health related field from an accredited institution; a licensed healthcare professional (ie, registered nurse); or equivalent work experience required
?    18 months of clinical monitoring experience required Knowledge of ICH and local regulatory authority regulations regarding drug (PREFERRED)
?    All therapeutic experience is welcome including but not limited to: Oncology, Hematology, Respiratory, Cardiovascular, Pain, CNS, Infectious Disease, Metabolism, Vaccines, Transplant and Ophthalmology
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities