Section: Human resources Vacancy 1311

Post:Clinical Study Manager (long-term contract)

Salary contractual

Requirements and conditions

Age:

Has no value

Gender

Has no value

Education:

Work schedule:

Has no value

Work place:

London

The announcement text:

We are seeking an experienced and dedicated
Clinical Study Manager for a long-term consulting opportunity
in the New York City/Northern New Jersey area!

Join a team with great group dynamics! Our client prides itself on the quality of the employees and the environment in which they work.

Contract length: Open-ended, long-term (2+ years)

Responsibilities:

Author drafts of study synopses, protocols, protocol amendments, Monitoring Plan and informed consents for Phase II-IV studies.

Contribute to the preparation of Investigator`s Brochures and IND annual reports.

Prepare study report shells. Contribute to or review drafts of study reports.

Provide input on CRF design.

Review, edit, check specifications with Data Management.

Operationally manage one or more clinical studies.

Participate in the development and review Statistical Analysis Plans.

Field clinical site operational questions during conduct of the clinical trial.

With TA management and other functional area input, work with Project Management to establish and revise timelines for studies/projects.

Closely monitor and track clinical trial progress as appropriate.

Review lab, ECG results of patients in clinical studies looking for evidence of toxicity (or for evidence at baseline that patients with significant abnormalities are being enrolled inappropriately).

Interact with PR & D to ensure that there is adequate clinical supplies for a given clinical trial.

Review clinical supplies package diagram and labeling.

Assist in planning Investigator Meetings.

Evaluate CROs and vendors (patient recruiting services, labs, centralized ECG) for participation in programs.

Assist with preparations for advisory board and regulatory agency meetings.

May contribute to scientific/clinical evaluation of potential in-licensing candidates.

May interact with Marketing to support commercialization of products.

Attend internal and external meetings.

Contribute to the development of documents such as INDs, ISE, ISS.

Assist in preparing briefing books, abstracts, manuscripts, poster presentations of clinical study findings and results.

Qualifications:

Bachelor`s or Advanced degree in life sciences

5-8 years experience in clinical research

Clinical trial management and protocol development experience preferred.

Medical and/or scientific knowledge in CNS and Cardiology trials desired.
Strong written and verbal communication skills

Proven ability to interact with different functional groups.

Knowledge of GCP/ICH guidelines and FDA regulations

Experience with clinical trial design

Basic knowledge of statistics

Good organizational, interpersonal and presentation skills

Proficiency in MS Office (Word, Excel, MS Project and PowerPoint).

Location: North NJ

Compensation: $60-$80/hour

This is a contract job.

Principals only. Recruiters, please don`t contact this job poster.

Please, no phone calls about this job!

Please do not contact job poster about other services, products or commercial interests.

Contact information

Employer:

Инком

Email:

public@dcmtm.com.

Phone:

Publication date: 2009-10-07 02:32:29

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Section: Human resources Vacancy 1311

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Section: Human resources Vacancy 1311

Vacancies
in Plymouth

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in Plymouth