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Clinical Study Program Manager

Employer
Planet Pharma Staffing Limited
Location
Munich (Stadt), Bayern
Salary
Per Annam
Start date
18 Jun 2021
Closing date
18 Jul 2021

Job Details

JOB SUMMARY

As clinical Study manager / Clinical Program manager you will be responsible for all clinical operational aspects pertaining to planning, start-up and management of assigned clinical Phase I and III trial, septically a Phase 3 biosimilar study in dermatology.

********* Will Consider Strong, Lead CRA & SCRA***********

Your Tasks and Responsibilities will include.

  • Identification, selection, and management of external service provider and CROs
  • Organizing and facilitating study team meetings and telephone conferences with external service partners
  • Co-development and review of study documents e.g. study protocol, informed consent form, monitoring guidelines, Case Report Forms, regulatory authority submissions
  • Overseeing and regular reporting of study progress to ensure successful completion within agreed timelines/ milestones and budget
  • Interactions with Regulatory Affairs, Drug Supply, Drug Safety and other relevant corporate functions or external development partners
  • Develop and control agreed study budget
  • Development of Standard Operating Procedures (SOPs)
  • Plans and actively contributes in GCP audits and inspections
  • Responsible for filing and maintenance of study/project documents

REQUIREMENTS

  • University degree or equivalent
  • Solid operational experience in Clinical Research for a minimum of 5 years on a global level
  • Proven track record of ICH-GCP training
  • Team player with solid project management skills to lead assigned clinical trials as a member of an international project team
  • Excellent computer skills
  • Excellent oral and written communication skills in English (primary language in the team

LOCATION

Location: Munich (Ideally 2 days per week)

DURATION

Permanent

SALARY

Competitive

ABOUT PLANET PHARMA

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its headquarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com

TO APPLY

  • If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on +44 (0) 20 3928 8388 or e-mail on jsmith@planet-pharma.co.uk
  • If this role is not suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!

Company

Planet Pharma was founded by a dedicated team of professionals with extensive experience supporting the pharmaceutical, biotechnology, and device industries.

Our goal is to create an organization that strengthens the employer-employee dynamic by connecting clients with talent. This results in making staffing more personal and creating enduring, valuable relationships. We value communication with our clients and make it our priority to have the hiring process be as fast and successful as possible.

We leverage cutting-edge technology and flexible service delivery models that provide efficient, personalized solutions for your business.

Our global headquarters is in Northbrook, IL and branch offices are based across the United States and Europe.

Company info
Website
Telephone
+44 203 868 1000
Location
10 Greycoat Place
London
England
SW1P 1SB
United Kingdom

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