Heather Bogle

**** ****** ***** ? Raleigh ?NC *7612 ? USA

acfmvy@r.postjobfree.com ?919-***-**** ?

RELEVANT EXPERIENCE

Oct2009-Present Project Group Manager, Almac Clinical Services - Durham

- Manage the Project Production department, a team of 14-

17 Project Managers and Project Coordinators to

successfully handle the packaging and distribution of

worldwide clinical supplies through the entire life

cycle of projects.

- Oversee the financial revenue generated by the

production group against the targets set for the Fiscal

year.

- Provide analysis on the department to ensure continued

progression to improve efficiencies.

- Evaluate the effectiveness of departmental procedures

through continuous assessment and collection of data and

audit reports. Utilize this information to identify

process improvements.

- Support, mentor and coach individuals to maintain a

positive work environment and promote growth within the

company.

- Monitor the resources and workload of the team and

implement change where necessary.

- Develop and implement a training program for the

department. Evaluate and modify the program to maximize

effectiveness.

- Manage the implementation of system integration projects

and customer specific processes.

- Manage business initiated projects to implement new

services / systems. Develop procedures for the

department to utilize.

- Track and report customer metrics / KPI's. Utilize the

data to drive improvement to customer service levels in

key areas of the business.

Oct2007-Oct2009 Project Manager, Almac Clinical Services - Durham

- Manage a team of 4 Associate Project Managers and

Project Coordinators to carry out the key tasks of the

project team.

- Responsible for timely delivery of projects and

management of project budget and scope. Analyze and

interpret information received from an existing or new

client to establish practical methods to package each

protocol.

- Oversight of inventory planning and product planning for

the drug supply for international and domestic studies.

- Analyze and interpret information from a protocol to

effectively package and distribute supplies using the

most efficient method for the study.

- Inform customers regularly of the progress of each

packaging run and alert the customer of any issues

arising throughout the course of the contract.

- Deal with internal and customer queries promptly. Ensure

all documentation generated by the team is of a high

standard, complies with Almac Clinical Services SOP and

GMP requirements.

Generate and implement training plans for all Associate

Project Managers and Project Coordinators.

Act as the main client contact. Liaise internally with

other departments to plan and control the project at

each stage of its completion, scheduling operations as

appropriate to meet customer target dates.

Dec 2006-Oct2007 Associate Project Manager, Almac Clinical Services -

Durham

- Manage projects independently with minimal guidance.

- Demonstrate effective problem solving skills. Take an

active role in process improvement.

- Generate detailed written batch record instructions for

packaging, labeling, distribution and destruction of

clinical supplies in accordance with the requirements of

GMP.

Perform the duties of Almac Clinical Services key

trainer for the project department.

- Act as the main client contact during the start-up and

the maintenance phase of the trial ensuring project

quality and excellent customer service.

Oct 2003-Dec 2006 Project Coordinator, Almac Clinical Services -

Durham

Create guidelines for assembly and distribution, and

coordinate initiation of updates and implementation of

changes.

Ensure development and maintenance of site flies.

Perform study monitoring duties for a current project.

Involved visiting 55 sites spread across USA and Canada.

Reviewed records to reconcile drug received and

dispensed to patients.

Track shipments of study drug and liaise with sites to

confirm delivery of shipments.

Coordinate label translation, generation, approval and

revision. Communicate with trial team and sites as

necessary.

- Act as a liaison between Project Management, Production,

Quality and Distribution to ensure on-time kit

production and shipping.

- Provide the facility with well written, thorough,

current, and mutually understood SOPs.

- Effectively communicate with individual teams so that

all processes are evaluated from a variety of

perspectives and each functional area has an opportunity

to provide insight on each SOP.

- Establish a global policy on the maintenance of blinding

across all Almac facilities.

Apr 2002-Oct 2003 Quality Control Supervisor, Almac Clinical Services

- Craigavon

- Delegate and prioritize tasks and operations to QC

Inspectors. Write and review QC standard operating

procedures. Identify report and follow through quality

incidents and customer queries.

- Update register of materials processed by Almac.

Identify any hazards and control risks. Advise

management on improvements to existing working

practices.

Implement, monitor and evaluate and document training of

QCT's. Participate in reviews and appraisals of QCT's.

Act as a point of contact in each area for queries from

internal departments.

Feb 2002-Apr 2002 Graduate Manager, Almac Clinical Services -

Craigavon

Completion and implementation of online database to capture

customer specific requirements. Improving CTS supplier

relations through construction of approved supplier list.

Liaison with IT department to establish a quality system to

control document templates. Writing of standard operating

procedures to support new systems and for training

purposes. Development of a product matrix through research

into analytical methods, leading to update of CTS cleaning

policy.

Oct 2001-Jan 2002 Graduate Manager, Almac Clinical Services -

Craigavon

Worked within Quality department to construct an approved Site Master

File for Medicines Control Agency and approved Quality

Manual for client review. Enhanced and implemented

reporting mechanism to monitor staff performance. Improved

and updated database of approved suppliers. Initiated the

set up of an online database to capture customer specific

requirements at Goods Receipt.

Jun 2000-Aug 2000 Student Analyst, Almac Sciences - Craigavon

Used analytical techniques (IR, UV-vis, NMR and HPLC) for

identification and purification of known/unknown chemical

compounds. Worked on own initiative to develop existing

HPLC methods by changing various parameters (resolution

time, solvent and type of column), to ensure successful

resolution for new compounds.

EDUCATION

Sept 1998-June 2001 Queens University of Belfast, Northern Ireland

B.Sc. (Hons) Chemistry

PROFESSIONAL TRAINING AND QUALIFICATIONS

Sept 2001-June 2002 Premiere, The Graduate Management Development

Program

35-week management training program including 22 weeks

placement.

ACHIEVEMENTS

. Circle of Excellence Award Nominations, April 2004

Nominated twice for showing a willingness to go the extra

mile assisting colleagues and for assisting with

evaluating, writing and implementing new procedures at CTS-

Durham.

. Graduate of the Year, June 2002.

Awarded by Premiere Graduate Management Development

Programme and Chartered Management Institute.

SPEAKING ENGAGEMENTS

Oct 2011 Presented "Avoiding the Oh No, Not Me! - Ways Supervisors and

Managers can be used as SME's" at GMPTEA Biennial Training

Conference, Orlando, FL.

Contact this candidate