Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Pharmiweb.com RSS Feed PharmiWeb Candidate Blog

Pharmiweb.com RSS Feed PharmiWeb Client Blog

Job Details

Investigator-sponsored studies (ISS) Manager - Home-based! Immediate start!

Company: DOCS Global
Location: Marlow,United Kingdom
Reference: Ref AS-020404
Closing Date: 21 Aug 17
Type: Contract
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Top Job

Job Summary:

Why Join DOCS? Work with the best! This is a great opportunity to further develop your career. To express your interest please send your CV today to find out more details to Elisabeth.Knighton@docsglobal.com or ring +33 964 25 67 65. *Applicants who have not had a response within two weeks should assume their application has been unsuccessful.

Requirements:

Roles & Responsibilities of the position

• Track receipt of investigator-initiated concepts / proposals and EA requests and facilitate / administer ISS or EA process as central point of contact
• Facilitate communication with Sponsor via collaboration with TA/Medical staff (e.g.: acknowledgement of receipt of proposal, provision of scienti?c comments on protocol for ISS or communication with requesting EA physician regarding next steps following request approval)
• Complete sponsor quali?cation process (in collaboration with TA /Medical staff as needed)
• Facilitate categorization, review and approval of proposals with medical personnel (including documentation)
• Initiate and ensure execution of Con?dential Disclosure Agreement where necessary
• Facilitate team review process sign off for proposals, protocols and amendments and submit for review by Regional Medical TA Head, GDL or review committee
• Support meetings internally and with Sponsor as appropriate (creating agendas, minutes, etc.)
• Provide protocol submission package (or open case package for EA) including product speci?c safety information, details of ISS (or EA) process and requirements to sponsor for protocol review and start-up activities
• Partner with Global / Regional Operations representative regarding drug forecasting including clinical trial labeling activities, expiry dates / memos as appropriate
• Partner with Global Clinical Pricing on budget negotiations and ensure conduct of Fair Market Value assessment
• Collaborate cross functionally to notify Sponsor of any actions or information required from Due Diligence process
• Initiate and support the contract execution process in collaboration with legal
• Support the collection of ISS Initiation Package documents (or regulatory documentation for EA) and forward for approval
• Enter data (e.g. milestone tracking, enrolment status) and maintain source systems
• Track essential documentation and archive in source system, etc..

Job Requirements

• BA / BS/ BSc in the sciences or RN
• In-depth experience in life sciences or medically related ?eld, including thorough knowledge of biopharmaceutical clinical research experience obtained as follows:
o for early development roles: clinical research experience obtained working on industry- sponsored or industry-partnered clinical trials at academic institutions, or working on clinical trials at a biotech, pharmaceutical or CRO company
o for clinical development roles: clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Experience in oversight of outside vendors (CROs, central labs, imaging vendors, etc.)
• Strong investigator-sponsored study experience gained within the industry at a Manager level.
• Influential and effective communication skills
• Excellent IT skills and ability to work fast and accurately across complex systems
• Valid and current UK working eligibility

Remuneration & other details

What is offered
• Permanent contract of employment
• Full-time
• Office-based in the UK, either in Marlow (near Maidenhead) or in Hampshire (Eastleigh).
• Home-working can also be an option for the right candidate
• Salary will depend on actual level of experience and skills
• UK benefits to include 25 days annual leave, car allowance, pension, healthcare cover, etc.

Apply for this job: Investigator-sponsored studies (ISS) Manager - Home-based! Immediate start!

Contact Information:

Address:  DOCS UK
2 Globeside, Globeside Business park Marlow
SL7 1HZ
England
Reasons to work for Docs International
Tel:  +44 (0) 2380 688500
Fax:  +44 (0) 2380 688501
Website:  Visit Our Web Site

Advertising
Share | | |
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.