南京招聘

Deliverables:

Base Level:

? Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies,

local regulatory requirements, ICH-GCP, etc.

? Provides scientific data review support for more than one low to moderate complexity trial or one

high complexity trial.

? The data management expert who, within the therapeutic area, is performing scientific (complex)

clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study

Responsible Scientists (SRS). Tapping into technical and clinical expertise, closely collaborating with

the SRP, SRS, Data Management functions and the rest of the study team members when

implementing the data management related activities for protocols, with focus on more complex

indication and therapy related elements of the study. Reviews all necessary data flows, the Data

Management Plans and performs continuous (complex) data review activities on the studies in the

assigned program.

? Involved in study related activities from the protocol design stage onwards, providing input into the

study specific and/or indication specific data collection tools.

? Reviews (complex) scientific study data, manages CDM and SRS/SRP related queries in eDC system

and holds discussions with SRS/SRP. Involvement in other review activitie s (e.g., Coding, SAE

reconciliation) is possible. Leads and/or attends meetings as appropriate.

? Takes a leadership role with SRP/SRS and collaborates with the GDM to establish, align and confirm

scientific clinical data review expectations for assigned trial(s).

? With the trial customer, CRO and other functional partners in relation to CDM related activities:

o Reviews content and integration requirements for eCRF and other data collection tools

o Establishes conventions and quality expectations for clinical data.

o Set timelines and follow‐up regularly to ensure delivery of all Clinical Data Management

milestones

? Creates the Integrated Review Plan ensuring appropriate quality, scientific content, organization,

clarity, accuracy, format, and consistency. Reviews related clinical data management documents.

Ensures compliance with regulatory guidelines and documentation requirements.

? Ensures real‐time inspection readiness of all assigned deliverables for the trial; participate in

Regulatory Agency inspection and J&J internal audits as necessary.

? Plans and tracks applicable CDM deliverables. Ensures CDM deliverables are on time.

? Takes a leadership role in collaborating with the SRS/SRP to ensure that DM and Therapeutic Area

trial needs and deliverables are met.

? Identifies and communicates lessons learned, best practices and frequently asked questions at th e

trial level.

? Identifies and participates in process, system, and tool improvement initiatives within clinical data

management.

? Acts as backup for GDM, as appropriate (for example, former GDMs for a short term).

Education and Experience Requirements/Qualifications:

Base Level:

o BS/BA degree or higher preferably in Health Sciences, or BS/BA degree or higher with

professional clinical experience/exposure.

o Data Management experience preferably including clinical data review or significant experience

with clinical data review. Knowledge in medical terminology would be preferable

o Collaboration with Clinical teams.

o Experience in clinical drug development within the pharmaceutical industry or related industry.

o College graduate: Data management experience or clinical data review.

We are a global provider of consulting, and outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.