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Lead Project Data Manager

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POST DATE 8/10/2016
END DATE 10/18/2016

Chiltern Wilmington, NC

Company
Chiltern
Job Classification
Full Time
Company Ref #
131059
AJE Ref #
575838635
Location
Wilmington, NC
Experience
Mid-Career (2 - 15 years)
Job Type
Regular

JOB DESCRIPTION

APPLY
LEAD PROJECT DATA MANAGER

JOB REFERENCE

131059

JOB BACKGROUND

JOB SUMMARY

Supervise and mentor assigned Clinical Data Management staff. Manage project budgets, timelines, resource planning, and overall quality of data management services of assigned projects/sponsors.

DUTIES & RESPONSIBILITIES

JOB RESPONSIBILITIES

- Evaluate and manage project budget against project milestones to ensure project profitability. Take corrective measures where necessary to keep project in line with budget and profit expectations. Track scope changes and obtain sponsor approval for change orders. Review, approve and follow-up on sponsor invoices.

- Supervisory position managing activities of Clinical Data Management staff assigned to specific sponsors. Perform Annual Employee Performance Evaluations.

- Establish appropriate project tracking using computer assisted programs and ensure timely entry of project information. Ongoing QC review of posted study documentation in study portal and in PMF for completion and audit readiness.

- Manage timelines for assigned protocol(s) and ensure that all applicable Clinical Data Management staff are aware and on target for all sponsor company deliverables. Manage sponsor expectations with regards to scope of work and deliverables. Ensure efficient cross functional handoffs.

- Escalate any potential or actual issues to supervisor, project team, and/or sponsor company in a timely manner with suggested resolution, and follow issues through to resolution.

- Ensure that Clinical Data Management staff documents initial and ongoing training as required by both Theorem and the sponsor company.

- Contribute to the development and/or revision of Clinical Data Management SOPs and related documentation.

- Present CDM function at conferences, external non-study meetings, etc. Attend Bid Defense Meetings and provide input into proposals as requested.



KEY SKILLS & BEHAVIORS

- Exemplifies, delivers and expects professionalism using strong interpersonal and organizational skills.

- Keeps internal and external sponsors informed of project and/or technical issues by pro-actively communicating across teams/functions.

- Manages and directly supervises assigned clinical data management team.

- Communicates effectively through both written and verbal methods.

- Anticipates changing priorities and demands and addresses them proactively.

- Manages time effectively in order to produce quality deliverables in expected timeframe.

- Exemplifies, delivers and expects professionalism using strong interpersonal and organizational skills.

REQUIREMENTS

TRAINING AND EXPERIENCE

1. Medical/Nursing, Life Science/Mathematical Degree or relevant experience.

2. 6+ yrs. experience, Experience leading multiple studies simultaneously.



When you re ready to join a company that s as dedicated to excellence as you are, THINK CHILTERN.

At Chiltern, you ll join a team of like-minded individuals headed by some of the most dynamic and influential leaders in drug and medical device development today. You ll work on cutting-edge global research projects in a fast-paced but collegial atmosphere where you ll have the opportunity to make meaningful and acknowledged contributions. You ll have opportunities to grow personally and professionally and abundant room for advancement along with generous incentive programs.


Chiltern is a leading midsized provider of comprehensive clinical research and development services with offices in more than 30 countries and a customer base comprised of some of the world's top pharmaceutical, biotech and medical device companies. As a forerunner in medical device and drug-device combination trials with notable capabilities in pharmaceuticals and biologics, Theorem offers deep expertise in a broad range of therapeutic areas and in all phases of development. With some of the industry's top scientists and most advanced clinical analytics capabilities, Theorem ensures smooth-running, successful trials. For the full-service, right-size global research partner, don't think twice.



THINK CHILTERN.

Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.

Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.

SALARY

Negotiable

POSITION TYPE

Permanent
Full Time

CONTACT

Email Jim Doyle
484 679-2497