Process Specialist-CDM/PV @ Cognizant

Job Description

JD CDM: 

1. 3.5 + yrs of minimum Clinical Data Management experience
2. Must have exposure to Study Start up, Conduct and Study Closeout. If not three phases should have good exposure to minimum two phases.
3. Rave (Medidata) or Veeva EDC hands on experience is must.

Must Have:

Setup experience should have knowledge of

DMP (Data Management Plan) creation, Edit check creation, Data Transfer specification creation, UAT knowledge (not mandatory).

Conduct Experience

Data Cleaning experience (Query Handling), Postproduction Changes, SAE reconciliation, LAB Reconciliation, ECOA/EPRO Reconciliation, PK/PD Reconciliation, Dataset review etc.

Study Lock

Freezing/Locking, should have good experience of Study lock

Client facing role and Mentoring are added advantage.

1 Execute Data Management Activities I.e., Data Cleaning, Executing Manual and System checks, Update relevant trackers, Discrepancy and query management, Issue resolution, Database lock activities. 

2 Participate in innovation and process improvement initiatives. 

3 Identify and develop action plan in coordination with the TL for activities not meeting the client SLAs. 

4 Archive all necessary information for audit purposes according to quality and security requirements, to ensure reliable and timely retrieval of documentation and information. 

5 Support multiple clinical trials, across diverse therapeutic areas, to successful conclusion and provide technical oversight when required.

6 Study Setup hands on experience.

7 Working exposure in RAVE/VEEVA EDC, Knowledge of Spotfire reporting tool , 

8 Third party data handling experience (Lab, PK, Image etc), Client facing role (experience in client communication

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0 - 1 Yrs 1 - 2 Yrs 2 - 3 Yrs 3 - 4 Yrs 4 - 5 Yrs 5 - 6 Yrs 6 - 7 Yrs 7 - 8 Yrs 8 - 9 Yrs 9 - 10 Yrs 10 - 11 Yrs 11 - 12 Yrs 12 - 13 Yrs 13 - 14 Yrs 14 - 15 Yrs 15 - 16 Yrs 16 - 17 Yrs 17 - 18 Yrs 18 - 19 Yrs 19 - 20 Yrs 20 - 21 Yrs 21 - 22 Yrs 22 - 23 Yrs 23 - 24 Yrs 24 - 25 Yrs 25 - 26 Yrs 26 - 27 Yrs 27 - 28 Yrs 28 - 29 Yrs 29 - 30 Yrs 30+ Yrs

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Rs 0 - 50K PM Rs 50K - 1 LPA Rs 1.0 - 1.5 LPA Rs 1.5 - 2.0 LPA Rs 2.0 - 2.5 LPA Rs 2.5 - 3.0 LPA Rs 3.0 - 3.5 LPA Rs 3.5 - 4.0 LPA Rs 4.0 - 4.5 LPA Rs 4.5 - 5.0 LPA Rs 5 - 6 LPA Rs 6 - 7 LPA Rs 7 - 8 LPA Rs 8 - 9 LPA Rs 9 - 10 LPA Rs 10 - 12 LPA Rs 12 - 14 LPA Rs 14 - 16 LPA Rs 16 - 18 LPA Rs 18 - 20 LPA Rs 20 - 22 LPA Rs 22 - 24 LPA Rs 24 - 26 LPA Rs 26 - 28 LPA Rs 28 - 30 LPA Rs 30 - 32 LPA Rs 32 - 34 LPA Rs 34 - 36 LPA Rs 36 - 38 LPA Rs 38 - 40 LPA Rs 40 - 42 LPA Rs 42 - 44 LPA Rs 44 - 46 LPA Rs 46 - 48 LPA Rs 48 - 50 LPA Rs 50 - 75 LPA Rs 75 Lakh - 1C PA Rs 1 Crore+ PA

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Keyskills:   data management data dmp lab pharmacovigilance conducting data cleansing review oracle clinical clinical trials reporting sae reconciliation medidata rave edc spotfire uat clinical data management mentoring rave check reconciliation veeva transfer clinical research slas