Category: Networking

What is networking?

Dictionary.com defines the noun as: a supportive system of sharing information and services among individuals and groups having a common interest  and the verb as: to cultivate people who can be helpful to one professionally, especially in finding employment or moving to a higher position.

I take it a step further by merging the two definitions in the forming of FOCM Networking. This is a site (system) for sharing information and services among individuals who have a diverse range of interests for the purpose of helping each other more than just professionally, but also socially and financially.

FOCM Card Ceremony May 2014

At the Wilmington Pharma/Bio/CRO Networking event on May 29, 2014 at The Bridge Tender restaurant in Wilmington, NC, two individuals received their FOCM membership cards. The moments of sheer joy were captured in the photos below:

Now Hiring Clinical Study Manager

Sigma-Tau Pharmaceuticals is looking for a Clinical Study Manager to work in their Washington, DC area office.

If you’re interested, send your resume to me at: chris@focmnetworking.com and I’ll get it in the right hands or you can search for it on LinkedIn and apply via the directions there. The job description is below:

Job description

POSITION PURPOSE:

The Incumbent will serve as a clinical representative for assigned projects. In association with his/her immediate supervisor, manage the development and implementation process of Sigma-Tau’s services involving the Clinical Affairs department or cross-functional teams focused on the delivery of new or existing projects. The Incumbent will monitor projects from concept through completion. (S)he will organize and coordinate the interdepartmental and outside vendor activities ensuring completion of the projects on schedule and within budget constraints to ensure success of the projects at all stages in the clinical process. The incumbent will also ensure compliance with applicable Sigma-Tau Standard Operating procedures and guidelines.

DAILY RESPONSIBILITIES:
For assigned projects:

In collaboration with department leads, manage the progress of clinical studies
Assure clinical study conduct is in compliance with Sigma-Tau SOPs, Good Clinical Practice Guidelines and federal regulations governing the conduct of clinical studies
Works with department leads to maintain projects within intended timelines and projected budgets
Identifies issues affecting study conduct and work with department leads on satisfactory resolution
Develops requests for proposal (RFP) and coordinates the selection of CROs and outside vendors

Manages outside vendors and contractors

Tracks key project metrics and action items

Tracks progress of all clinical study activities, including regulatory compliance, site selection, enrollment, site monitoring, drug supply, adverse events/serious adverse events, data management, biostatistics, and medical writing

Assist with the development of study protocols

Assist with the development of study timelines and budgets

Track vendor and site payments Develops and/or coordinates the development of documents in support of clinical studies (CRFs, ICFs, manuals, etc)
Work with internal departments and external vendors to establish appropriate study processes to ensure compliance with guidance’s and regulations.

Reports progress of clinical projects to management Participate in the development, review and approval of vendor agreements and budgets

Assesses training needs for Clinical Affairs project staff; conducts and documents training of team members
Oversee study activities by Sigma-Tau staff, vendors, and contractors
Supports site management and monitoring efforts as needed

Monitoring of select sites to assure protocol & GCP compliance

Participate in the development, review and maintenance of Clinical Affairs SOPs

Other duties as assigned

SPECIFIC JOB KNOWLEDGE, SKILL AND ABILITY:

RN or Bachelor’s degree within a health/biomedical sciences field, or related field and equivalent experience.

4+ yrs experience in clinical research with the monitoring and/or management of clinical studies in the pharmaceutical industry or at a CRO with experience in managing multi-center study set-up and execution.

Knowledge of GCP, ICH guidelines and US FDA regulatory requirements for the conduct of clinical trials.
Strong critical thinking skills.
Strong ability to prioritize and organize workflow activities in a fast-paced environment.
Proficient in basic computer programs such as MS Office Suite and MS Project.
Excellent communication skills; ability to tactfully communicate sensitive information.
Ability to work independently and in a cross-functional team environment.

Must demonstrate excellent planning and organizational skills and an ability to generate creative solutions for complex problems.

Basic understanding of clinical development, regulatory and QA, CMC, clinical trials operations and project management methodology.
Ability to travel at least 20% of the time.

Job Opportunity Global Head of Consumer and Professional Marketing

ZetrOZ Inc, a consumer wellness and healthcare company based in Trumbull, CT, is seeking an experienced consumer and professional healthcare marketing professional to deliver savvy marketing strategies and tactics to help drive product revenues and grow the organization. Looking for someone with 12-20 years experience, who understands and thrives in startup lifestyle; fast-paced, strategic and tactical, eager to roll up the sleeves and get to work.

They are a fun, innovative, team playing group. Job description is in the link below. You can have resumes sent to me (chris@focmnetworking.com) and I will forward them or you can reply directly to co-founder George Lewis (george@zetroz.com) and mention you saw it on FOCM Networking. (They’re a startup – so we’re relying on networking, no recruiters.)

ZetrOZ is revolutionizing the medical therapeutic industry with its proprietary technology, including the recently introduced sam®, sustained acoustic medicine, (www.samrecover.com) and UltrOZ® (www.ultroz.com), miniature wearable ultrasound devices for accelerated recovery and pain management.

FOCM_Consumer & Professional Healthcare Marketing for ZetrOZ Oct 9 2014

Another FOCM Card Ceremony

It was a joyous occasion when Amy Bowers, sister of FOCM member Wendy Revenaugh was visiting Wilmington. Her exuberance, sense of humor and having traveled all the way from San Diego for the event earned her an instant membership card.

FOCM Welcomes Peter Benton

At the Drug Information Association Annual meeting in San Diego, Peter Benton received his FOCM card. This photo does not adequately capture the sheer joy that Peter experienced during the ceremony. Peter has been diligently working to complete the secret membership requirements for a couple of years. Having finally been deemed worthy, I surprised him with an impromptu card ceremony.

Two New FOCM Members

At the Outsourcing in Clinical Trials -East Coast meeting in May two new members joined FOCM. Pete Nieto (in his usual spot in the bar) introduced me to Michele Grabowski and Michele introduced me to Karen Pypniowski. That was one of the quickest time from first meeting to initiation in FOCM that has been ever recorded since the organization first began recording this data. Pete and Michele (Karen’s sponsors) are visible in the background of Karen’s ceremony.

How to avoid looking old on a resume

https://www.linkedin.com/pulse/article/20141013131941-4524580-what-does-your-resume-say-about-your-age?trk=tod-home-art-list-large_0

I saw this via LinkedIn and it’s a good article for those over 50 to read about how to adjust your resume.

Business advice in the information age

I saw this on LinkedIn and is a great way of thinking about and running a successful business in this age of information accessibility. It is how Google works.

http://www.slideshare.net/ericschmidt76/how-google-works-final-1

FOCM Members New and Old

At the Outsourcing in Clinical Trials -East Coast meeting in May, several existing FOCM members were spotted and quite a few new members received their cards. Daneil Dixon was seen setting up her booth but no photos were allowed, Kris Kuhner was walking through the exhibit hall with purpose and Pete Nieto was in the bar. Suzanne Besse and Lisa Banket with Pharmavoice, Pippa Wilson and Christina Alexander Smith with Barrington James and Bryan Clayton with Y-Prime all received their cards in a very busy meeting for FOCM.

Bryan Clayton

FOCM Member and Business Spotlight – Julia Parker

One of the benefits of paying one’s annual FOCM Networking membership (an incredible value at $20/year) is that you get either your business or yourself highlighted in the prestigious “Spotlight”. The first Corporate Member Spotlight featured RxTrials where FOCM member Adam Chasse is the COO and the first Member Spotlight featured Vicky Martin. This is the first spotlight to feature both a person and a business – Julia Parker/Julia Parker Designs.

How do I know Julia and when did I first meet her:
I was introduced to Julia electronically through our mutual friend, Kelly O’Brien. Kelly and I worked together for about 10 years. While Julia and I have not met in person, we were several miles apart in June of this year.

Julia’s bio: Julia comes to the FOCM Network via referral from Kelly O’Brien. Julia grew up in Columbia, NC and graduated from NC State University. Julia currently lives in San Diego, CA.

Spotlight
While it was January 2014, when Julia started Julia Parker Designs (http://juliaparkerdesigns.com/), she has been metalsmithing and doing custom work for 4 years. Julia Parker Designs includes something for everyone – men, women and even children. As you’ll see on her website her Numeral Line (http://juliaparkerdesigns.com/?product_cat=numeral) was designed around the numbers one through nine and each of the pieces holds a subtle representation of its number. The meanings for each of the numbers are listed and people can choose the piece that represents the things they are looking for in their lives or they can choose the piece they are drawn to stylistically. Julia also will work with people to determine their number in numerology if they would like to choose a piece based on that or the number of their family. The rings in the collection are unisex so they work for lots of different styles. The bangles are solid and substantial with a very unique style.

The Bond Bangles (http://juliaparkerdesigns.com/?product=fine-silver-bangles-copy) were created to celebrate mothers and daughters but have expanded to celebrate sisters, best friends, bridesmaids and any of the other special women you want to honor in your life. The fine silver aspect of them is great because they never tarnish even if you get them wet. They are also malleable so they conform to the shape of your wrist and really become yours.

If you’re looking for a gift for someone with a new baby girl coming along the As She Grows (http://juliaparkerdesigns.com/?product=as-she-grows-fine-silver-bangles) bangles are great because they celebrate the stages of a little one’s life. These are also made from fine silver and they can passed down for generations to come.

Julia Parker Designs also has some fun earrings (http://juliaparkerdesigns.com/?product_cat=earrings) on the site. And she absolutely love to do custom work. It’s important for her to know the people who will be wearing her work and she wants to put the thought of them into their pieces.