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Clinical Trial Specialist

Post Date:Dec 27, 2017Type:Full-Time
Start Date:12/27/2017Salary:$36.00
Location:US-NJ-Hanover Job Reference:
Skills:

Education Requirement(s):

 

The incumbent must have an associate’s degree (or equivalent) and 5-7 years of clinical research/development experience or a bachelor’s degree (or equivalent) with 2 - 3 years of experience in clinical research/development in the pharmaceutical industry.

 

Skill & Competency Requirements:

  • The incumbent must have the ability to manage multiple high level

parallel tasks; work unsupervised, have effective computer skills,

 

possess the ability to apply new techniques, and strong prioritization skills.

  • Must display effective planning and organizational skills, innovativeness,

and keen attention to detail and excellent follow through.

  • The incumbent must have strong interpersonal skills in working with highly qualified

teams, 3rd parties and people in a global environment.

  • Excellent written and oral communication skills.

Preferences:

 

SharePoint

 

Pay rate: $33.00 to $36.00 per hour.

 

Travel Requirements: N/A

 



Job Description:

Exciting opportunity to work for a global leader in the pharmaceutical industry. We have an immediate opening for an experienced Clinical Trials Specialist. This incumbent must be polished, professional and extremely reliable. Our ideal candidate will have pharmaceutical or CRO experience.

 

Position Summary

 

The Clinical Trial Specialist contributes to the organization’s drive for business quality and efficiency by being responsible for facilitating and providing efficient study support and expertise to the global study management teams. The CS study and project coordination activities are accomplished because of a strong skillset, understanding of clinical science operations and global operating processes of drug development within the complex boundaries of an early phase study.

 

CS Clinical Trial Specialist (CTS) collaborates with the OPLs, Study Managers, Study Teams, CRO’s, and other key stake-holders for the global trial initiation conduct and reporting of trial progress by coordinating and performing assigned development and operational activities. The CTS is instrumental in enabling Global Clinical Program and Study Management in achieving efficiency, compliance, quality as well as project/study milestones in both internally managed and outsourced complex clinical projects and trials. The CTS is expected to directly liaise with OPL and StM (and ECL as applicable), and play an active role in operational oversight, logistical planning, project and study status monitoring, corrective action planning, systems support and study communications. Provide overall operational technical support and expertise for managing programs and studies.

 

Responsibilities

 

These global studies are conducted within the standards set by Global Development, according to Good Clinical Practices (GCP) and applicable regulatory and legal requirements and include the key operational responsibilities for CTS:

 

1. Maintain global operational tracking and reporting systems and tools including but not limited to he study/project budget and financial management data), YourDOCeS (invoices), IMPACT (updates for planned/concept studies), ShareDoc PhlexGlobal (eTMF documents), Quality Risk Indicator systems, eFilia (contracts), Study drug destruction trackers etc. Develop study specific tracking systems if applicable.

 

2. Provide detailed support for cost tracking (study budgets, project budgets and special events. Exercise clear decision making on invoice reconciliations based on knowledge of the protocol, patient visit design, lab draw timings and other study specific parameters that require understanding of the therapeutic area specifics and study conduct.

 

3. Provide technical and administrative support and expertise for contract tracking by acting as a main point of contact for contract handling and by liaising globally with internal and external partners to facilitate progress and identify potential issues.

 

4. Assist with oversight of study metrics, compliance with systems use and present/report issues, progress, and status at global meetings via written and verbal communication (if applicable).

 

5. Assist and collaborate in development of project / study related documents. Support Clinical Study Report preparation (e.g. appendices) if applicable.

 

6. Coordinate project / study material preparation and global study communication internally and/or with vendors:

  • Consistent and collaborative communication to internal (CSM, cPharm, GCS –ECL, OPL, STM, CLM, CRA, etc.) and external partner (CRO, Laboratory, etc.).
  • Create and send communications materials to countries and/or study sites (e.g. Newsletters, updates, etc.).
  • Support the maintenance and construction of study specific internet based forums, such as study websites, SharePoints, Investigator Portal, etc.
  • Coordinate communication of project/study status to various levels of management

7. Provide meeting coordination for the global clinical and study team members (StM, OPL, cPharms) in scheduling, agenda, presentations, arrangements, minutes, and action item tracking including global and regional investigator meetings, global/regional monitor training meetings (if applicable) and advisory committee meetings as requested by ECL/OPL.

 

8. Responsible for setting up, maintaining on ongoing basis, providing expertise in quality controlling and archiving of the global Trial Master File (TMF) (paper TMF or eTMF) – including but not limited to Study Files. Provide technical knowledge of the “essential documents" as described in the SOPs and required by the global regulatory authorities (FDA, SFDA, PMDA, MOH EMA, etc.). Provide proactive, close support to Study Manager with quality control and verification of the TMF managed/maintained by external suppliers. Participate and support audits (Regulatory Authorities and the QA), inspections and verification of TMF. Ensure the quality, completeness, availability and quality of the clinical study documents in the Trial Master File to enable final compilation of the documents for regulatory submissions and approval of new medications and medical devices.

 

9. Provide expertise in non-project activities

  • Provide technical expertise for the eTMF.
  • Provide consultative guidance on new systems, processes and procedures (e.g. SharePoint, inspection readiness, etc.)
  • May represent GCP&SM Support Service in areas of various initiatives (e.g. as representative or leader of the expert working groups,) Actively suggest means to increase efficiency and other improvement measures
  • Provide technical expertise of the budget and payment systems (YOUR-DoceS, for assistance with forecasts, actual cost updates, etc.) Provide expertise with the use of SOP repository (QDoc and others as necessary).
  • Support to functional Heads of ECL&OPLs in presentations, organizing trips, equipment ordering, and other general tasks.




Contact Information

Name: Viannys Diaz
Ph: 973-839-4401


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